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Article Continuing Education| Volume 26, ISSUE 5, P320-331, September 2012

Evidence-Based Care of the Child With Deformational Plagiocephaly, Part II: Management

      Abstract

      Non-synostotic deformational plagiocephaly (DP) is a common condition that affects as many as one in five infants in the first 2 months of life. The purpose of this article, the second in a two-part series, is to present a synthesis of the evidence related to management of deformational plagiocephaly and an evidence-based clinical decision tool for multidisciplinary management of DP. We systematically reviewed and graded the literature on management of DP from 2000 to 2011 based on level of evidence and quality. The evidence suggests that although many cases of DP will improve over time, conservative management strategies such as repositioning, physical therapy, and cranial molding devices can safely and effectively minimize the degree of skull asymmetry when implemented in the first year of life. Outcomes are best when the timing of diagnosis and severity of asymmetry guide decision making related to interventions and referrals for DP. Prevention and management of early signs of DP are best achieved in a primary care setting, with multidisciplinary management based on the needs of the child and the goals of the family.

      Key Words

      Objectives
      • 1.
        Describe evidence-based management strategies for the infant with nonsynostotic deformational plagiocephaly.
      • 2.
        Distinguish among various conservative management strategies for deformational plagiocephaly based on the age of the infant and the severity of asymmetry.
      • 3.
        Describe the aim of physical therapy for infants with deformational plagiocephaly and torticollis.
      Deformational plagiocephaly (DP), also known as “positional plagiocephaly” or “non-synostotic plagiocephaly,” is characterized by changes in skull shape that result from mechanical forces prenatally or postnatally. DP is a common condition in infants and affects as many as one in five infants in the first 2 months of life (
      • van Vlimmeren L.A.
      • van der Graaf Y.
      • Boere-Boonekamp M.M.
      • L’Hoir M.P.
      • Helders P.J.
      • Engelbert R.H.
      Risk factors for deformational plagiocephaly at birth and at 7 weeks of age: A prospective cohort study.
      ). Without intervention, this condition can worsen over time and in severe cases may be associated with cosmetic and neurological problems (
      • Bialocerkowski A.E.
      • Vladusic S.L.
      • Wei Ng C.
      Prevalence, risk factors, and natural history of positional plagiocephaly: A systematic review.
      ). In mild cases, parental concern and unclear guidelines for management in primary care may lead to unnecessary diagnostic tests and referrals. This article is the second in a two-part series on the assessment, diagnosis, and evidence-based management of DP. In the first part of this series (
      • Looman W.S.
      • Flannery A.B.K.
      Evidence-based care of the child with deformational plagiocephaly, part I: Assessment and diagnosis.
      ), we presented a brief background of DP, associated problems with torticollis and infant development, and strategies for visual and anthropometric assessment of the infant skull. We also provided a diagnostic tool for determining the type and severity of lateral and posterior DP.
      Evidence-based guidelines for clinical decision making in the management of DP are needed in primary care and specialty settings. In 1999, Najarian published an original article in the Journal of Pediatric Health Care that presented an informative review of infant positional plagiocephaly and implications for primary care providers, noting the absence of standardized diagnostic and treatment guidelines at that time (
      • Najarian S.P.
      Infant cranial molding deformation and sleep position: Implications for primary care.
      ). Despite continuing research in the field during the 12 years since that publication, management strategies for DP in primary care continue to vary by practitioner, guided by expert opinion rather than evidence or consensus. This article addresses the need for evidence-based strategies for the management of DP through a synthesis of current evidence related to conservative management strategies. This evidence is summarized in a clinical decision tool (presented in the Figure) for determining the appropriate course of treatment based on infant age, severity of the condition, and response to treatment over time.
      Figure thumbnail gr1
      FigureClinical decision-making tool for management of deformational plagiocephaly. Notes: (a) Early intervention is essential; (b) referral/comanagement with craniofacial team, at any age, is appropriate (referral is indicated when diagnosis is unclear, asymmetry is severe at 4 months or older, or when provider desires additional input); (c) begin collaborative management as appropriate; (d) enter algorithm based on current age of infant; (e) exit algorithm (continue routine monitoring of growth and development at well-child visits with primary care provider); (f) consider referral to craniofacial team for consideration of alternative diagnosis and/or management; and (g) helmet therapy is likely to improve cosmetic outcome at this point. This figure appears in color online at www.jpedhc.org.

      Method: Critical Appraisal of the Evidence

      The purpose of our systematic review of the literature was to identify the most current, relevant evidence regarding clinical management on non-synostotic DP to guide clinical decision making in primary care. We searched the online databases MEDLINE (using the MeSH heading “plagiocephaly, non-synostotic”) and CINAHL (using the major subject, “deformational plagiocephaly”). We limited the search to peer-reviewed research reports published in the year 2000 or later. From this search, 129 articles were retrieved. We eliminated 56 articles because they were letters, comments, or editorials (16); duplicates (12); non-English (12); not focused on primary non-synostotic plagiocephaly (10); historical/anthropological (3); patient handouts (2); or non-human (1). Of the remaining 73 relevant research articles, 26 were specifically related to management of deformational plagiocephaly. Three of these articles were systematic reviews and the remaining 23 were reports of research on the effectiveness and safety of interventions to manage this condition in children.
      We reviewed the 26 articles and graded the evidence by strength and quality using two methods. First, we rated the strength of evidence according to the hierarchy described by
      • Fineout-Overholt E.
      • Melnyk B.M.
      • Stillwell S.B.
      • Williamson K.M.
      Evidence-based practice, step by step: Critical appraisal of the evidence: Part III.
      , which rates systematic reviews and meta-analyses as the highest level of evidence, and expert opinion and consensus as the lowest level of evidence (Table 1). Second, we reviewed each of the 23 studies and rated them for quality using the Critical Review Form for quantitative studies by

      Law, M., Stewart, D., Pollock, N., Letts, L., Bosch, J., & Westmorland, M. (1998). Critical review form: Quantitative studies. Retrieved from http://www.srs-mcmaster.ca/Portals/20/pdf/ebp/quanguidelines.pdf

      . Using this tool, the reviewer assigns one point for each of the following criteria: purpose clearly stated; literature review relevant; research design appropriate to answer aims; no bias introduced into the study; sample described in detail; sample size justified; informed consent gained; reliable outcome measures used; validated outcome measures used; intervention described in detail; results reported in terms of significance; analysis appropriate; clinical importance reported; conclusions appropriate; clinical implications reported; and acknowledgement of limitations of the study. The Critical Review Form for quantitative studies has demonstrated good inter-rater reliability (
      • Bialocerkowski A.E.
      • Vladusic S.L.
      • Howell S.M.
      Conservative interventions for positional plagiocephaly: A systematic review.
      ). Articles also were classified into one or more of the following categories according to the purpose of the study: timing of treatment, positioning and/or physical therapy interventions, surgical interventions, and interventions using orthotic devices such as helmets, cups, and pillows. Table 2 provides the results of this review.
      Table 1Hierarchy of evidence for appraisal of deformational plagiocephaly literature
      LevelType of evidence
      ISystematic review or meta-analysis
      IIRandomized controlled trial
      IIIControlled trial without randomization
      IVCase-control or cohort study
      VSystematic review of qualitative or descriptive studies
      VIQualitative or descriptive study
      VIIExpert opinion or consensus
      Table 2Review of evidence related to clinical management of deformational plagiocephaly
      Author(s)/yearDesign (level of evidence
      Level of evidence based on hierarchy in Fineout-Overholt et al. (2010).
      )
      Quality score
      Quality rating (0-16) based on criteria in Law et al. (1998). One point was awarded for each of the following criteria: purpose clearly stated; literature review relevant; research design appropriate to answer aims; no bias introduced into study; sample described in detail; sample size justified; informed consent gained; reliable outcome measures used; validated outcome measures used; intervention described in detail; results reported in terms of significance; analysis appropriate; clinical importance reported; conclusions appropriate; clinical implications reported; acknowledgement of limitations of the study.
      Age at tx (mo)Main findingsFocus of study
      Timing of treatmentPositioning ± PTSurgeryDevice
      • Bialocerkowski A.E.
      • Vladusic S.L.
      • Howell S.M.
      Conservative interventions for positional plagiocephaly: A systematic review.
      Systematic review (I)Counter-positioning with or without physical therapy or helmet therapy may reduce skull deformity; no criterion standard outcome measure to quantify skull asymmetry; level of evidence as of 2003 was moderate to poor
      • Robinson S.
      • Proctor M.
      Diagnosis and management of deformational plagiocephaly.
      Systematic review (I)Mild deformity can be treated with repositioning and physical therapy, severe deformity is likely to be treated more effectively and quickly with helmet therapy than with repositioning and physical therapy; level of evidence limited by methodological bias and lack of RCTs as of 2009
      • Xia J.J.
      • Kennedy K.A.
      • Teichgraeber J.F.
      • Wu K.Q.
      • Baumgartner J.B.
      • Gateno J.
      Nonsurgical treatment of deformational plagiocephaly: A systematic review.
      Systematic review (I)Molding therapy may reduce skull asymmetry more effectively than repositioning therapy; repositioning therapy preferred over helmet therapy in infants 4 mo or younger with non-severe DP; molding therapy is preferred for infants 6 mo or older or who have severe DP; treatment choice between 4 and 6 mo is controversial; level of evidence limited by methodological bias and lack of RCTs as of 2007
      • Carson B.S.
      • Munoz D.
      • Gross G.
      • VanderKolk C.A.
      • James C.S.
      • Gates J.
      • Guarnieri M.
      • et al.
      An assistive device for the treatment of positional plagiocephaly.
      Case-control (IV)71.5-12An AD worn during sleep led to good to excellent results in 62 of 68 infants with moderate to severe DP; the device was less effective for infants > 7 moXAD
      • David D.J.
      • Menard R.M.
      Occipital plagiocephaly.
      Cohort (IV)51.5-24204 infants with DP (84 mild, 90 moderate, 30 severe) underwent positioning ± PT; 19 with severe deformities underwent surgical treatment; 94% had subjectively acceptable improvement; 2 surgical patients and 1 infant followed conservatively had no notable improvement by parent reportXX
      • de Ribaupierre S.
      • Vernet O.
      • Rilliet B.
      • Cavin B.
      • Kalina D.
      • Leyvraz P.F.
      Posterior positional plagiocephaly treated with cranial remodeling orthosis.
      Cohort (IV)53-18TDD measurements of 147/260 patients with DP significantly improved after a single helmet; good results were obtained for 98 and 15 infants with 2 and 3 helmets, respectively; tx duration was not significantly different for infants treated before or after 6 mo of ageXH
      • Elwood E.T.
      • Petronio J.
      • Wood R.J.
      Parental satisfaction with the CranioCap: A new cranial orthosis for deformational plagiocephaly.
      Cohort (IV)9< 12Parents of 81 infants with DP treated with an orthotic device reported head shape improvement 4.06 out of 5 on a Visual Analog Scale; all indicated they would recommend the device to othersH
      • Govaert B.
      • Michels A.
      • Colla C.
      • van der Hulst R.
      Molding therapy of positional plagiocephaly: Subjective outcome and quality of life.
      Case-control (IV)86.6 +/−2.246 children treated for DP with molded helmet therapy had similar quality of life scores 2.4 to 4-8 years after treatment compared with 251 healthy control subjectsH
      • Graham Jr., J.M.
      • Gomez M.
      • Halberg A.
      • Earl D.L.
      • Kreutzman J.T.
      • Cui J.
      • Guo X.
      Management of deformational plagiocephaly: Repositioning versus orthotic therapy.
      Retrospective cohort (IV)121-6Among infants with DP treated with repositioning (176) or helmet therapy (159), there was improvement for both groups, but helmet therapy was more effective statistically; infants treated with helmets were older and treatment was longerXXH
      • Graham Jr., J.M.
      • Kreutzman J.
      • Earl D.
      • Halberg A.
      • Samayoa C.
      • Guo X.
      Deformational brachycephaly in supine-sleeping infants.
      Retrospective cohort (IV)123-12Change in cephalic index for 96 infants with DP treated with repositioning was not significant; change in cephalic index for 97 infants treated with helmet therapy was significant; for infants treated with helmet therapy, treatment at a younger age resulted in more improvementXXH
      • Hutchison B.L.
      • Stewart A.W.
      • De Chalain T.B.
      • Mitchell E.A.
      A randomized controlled trial of positioning treatments in infants with positional head shape deformities.
      RCT (II)12< 12126 infants with DP were randomized into a positioning group or device group (sleep positioning wrap); there was no difference in head shape outcomes for the 2 groups after 12 mo of follow-up (42% had head shapes in normal range at that time); most rapid improvement was in the first 3 mo of treatmentXXAD
      • Jalaluddin M.
      • Moss D.S.
      • Shafron D.H.
      Occipital plagiocephaly: The treatment of choice.
      Case-control (IV)32-7303 infants treated with repositioning and neck stretching (166) or orthotics (headband or helmet, 137) were compared at 3 to 5 y; repositioning and stretching was as effective as orthotic devices in the long-term comparison of outcomesXAD, H
      • Lee W.T.
      • Richards K.
      • Redhed J.
      • Papay F.A.
      A pneumatic orthotic cranial molding helmet for correcting positional plagiocephaly.
      Cohort (IV)11< 12Infants with DP treated with a pneumatic orthotic helmet had significant improvements over baseline, correcting DP without hindering cranial growthXH
      • Lee R.P.
      • Teichgraeber J.F.
      • Baumgartner J.E.
      • Waller A.L.
      • English J.D.
      • Lasky R.E.
      • Xia J.J.
      • et al.
      Long-term treatment effectiveness of molding helmet therapy in the correction of posterior deformational plagiocephaly: A five-year follow-up.
      Cohort (IV)11< 1228 infants with DP with helmet therapy showed significant improvements in symmetry during the 6-mo helmet molding period; no significant changes were noted in the post-treatment period (5.6 y)XH
      • Lipira A.B.
      • Gordon S.
      • Darvann T.A.
      • Hermann N.V.
      • Van Pelt A.E.
      • Naidoo S.D.
      • Kane A.A.
      • et al.
      Helmet versus active repositioning for plagiocephaly: A three-dimensional analysis.
      Case-control (IV)132-735 helmeted and 35 actively repositioned infants with DP were compared using 3D scans to quantify symmetry before and after treatment (mean tx time 3–5 mo); the helmeted group had significantly greater reduction in asymmetry immediately after treatment.XH
      • Losee J.E.
      • Mason A.C.
      • Dudas J.
      • Hua L.B.
      • Mooney M.P.
      Nonsynostotic occipital plagiocephaly: Factors impacting onset, treatment, and outcomes.
      Retrospective cohort/case control (IV)83-14Cranial molding helmet therapy after repositioning therapy (N = 45) was more effective in treating DP than repositioning alone (N = 100); treatment success was not influenced by age of initiation of therapyXXH
      • Loveday B.P.
      • de Chalain T.B.
      Active counterpositioning or orthotic device to treat positional plagiocephaly?.
      Retrospective cohort (IV)66-12+74 infants with DP were managed with active counter-positioning (N = 45) or helmet therapy (N = 29); at the end of the treatment period, infants treated with helmet therapy had outcomes comparable with those who underwent repositioning, with a treatment time that was approximately 3 times shorterXH
      • Marchac A.
      • Arnaud E.
      • Di Rocco F.
      • Michienzi J.
      • Renier D.
      Severe deformational plagiocephaly: Long-term results of surgical treatment.
      Retrospective cohort (IV)715-3430 infants with severe DP who were treated with surgical correction after the age of 15 mo were assessed at least 1 y after correction; none were treated with repositioning in the first year of life; 9 incidents involving dural tear or venous sinus breaches occurred, with 6 patients requiring blood transfusions; long-term morphological results ranged from poor to excellentXX
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      Case-control (IV)123-12207 infants with moderate to severe DP treated with helmet therapy were compared with control subjects (no treatment); infants treated with helmet therapy improved significantly compared with control subjects; 96% of helmeted infants improved; > 30% of infants in the control group had worsening symmetryH
      • Rogers G.F.
      • Miller J.
      • Mulliken J.B.
      Comparison of a modifiable cranial cup versus repositioning and cervical stretching for the early correction of deformational posterior plagiocephaly.
      Prospective cohort with historical control subjects (IV)8< 447 infants with DP and head rotational preference were treated with a modifiable cranial cup (N = 24) or repositioning and PT (N = 22) for 2 mo; the cup was more effective for correcting head shape than repositioning and PT; both groups had improvement in cervical muscle imbalanceXXAD
      • Steinbok P.
      • Lam D.
      • Singh S.
      • Mortenson P.A.
      • Singhal A.
      Long-term outcome of infants with positional occipital plagiocephaly.
      Case-control (IV)103-16No difference in cosmetic or developmental outcomes of 18 children with and 47 children without orthotic use at 5 or more years of ageXH
      • Teichgraeber J.F.
      • Ault J.K.
      • Baumgartner J.
      • Waller A.
      • Messersmith M.
      • Gateno J.
      • Xia J.
      • et al.
      Deformational posterior plagiocephaly: Diagnosis and treatment.
      Retrospective cohort (IV)10< 12125 infants with moderate to severe DP were treated with helmet therapy with or without physical therapy; cranial vault and cranial base asymmetry decreased significantly with treatment; age at which treatment was begun did not predict treatment outcomesXXH
      • Terpenning J.F.
      Static orthotic cranioplasty as a nonsurgical alternative for the treatment of deformational plagiocephaly.
      Cohort (IV)65-1412 infants with DP treated with helmet therapy had significant correction in skull asymmetry; infants who began orthotic treatment by the age of 6 mo had the highest rate of symmetry improvementXH
      • Thompson J.T.
      • David L.R.
      • Wood B.
      • Argenta A.
      • Simpson J.
      • Argenta L.C.
      Outcome analysis of helmet therapy for positional plagiocephaly using a three-dimensional surface scanning laser.
      Cohort (IV)61-12116 infants with DP were treated with helmet therapy; significant improvement was achieved, with a positive correlation with compliance with helmet protocol; infants initially treated between 4 and 8 mo of age had the best outcomesXH
      • van Vlimmeren L.A.
      • van der Graaf Y.
      • Boere-Boonekamp M.M.
      • L’Hoir M.P.
      • Helders P.J.
      • Engelbert R.H.
      Effect of pediatric physical therapy on deformational plagiocephaly in children with positional preference: A randomized controlled trial.
      RCT (II)162-668 infants with DP and positional preference were randomized to either a 4-mo standardized PT intervention or usual care; the proportion of infants in the intervention group with severe DP decreased significantly compared with the control group; no infant demonstrated positional preference at 12 moX
      • Vles J.S.
      • Colla C.
      • Weber J.W.
      • Beuls E.
      • Wilmink J.
      • Kingma H.
      Helmet versus nonhelmet treatment in nonsynostotic positional posterior plagiocephaly.
      Prospective cohort (IV)9NR105 infants with DP were treated with helmet therapy (N = 85) or no helmet (N = 20); improvement (cosmetic outcome) was significantly better in the helmet groupH
      Note. Systematic reviews were not rated.
      AD, Assistive device (band, foam pillow, cup, or wedge); DP, deformational plagiocephaly; H, helmet; NR, not reported; PT, physical therapy; RCT, randomized controlled trial; TDD, transcranial diameter difference; tx, treatment.
      a Level of evidence based on hierarchy in
      • Fineout-Overholt E.
      • Melnyk B.M.
      • Stillwell S.B.
      • Williamson K.M.
      Evidence-based practice, step by step: Critical appraisal of the evidence: Part III.
      .
      b Quality rating (0-16) based on criteria in

      Law, M., Stewart, D., Pollock, N., Letts, L., Bosch, J., & Westmorland, M. (1998). Critical review form: Quantitative studies. Retrieved from http://www.srs-mcmaster.ca/Portals/20/pdf/ebp/quanguidelines.pdf

      . One point was awarded for each of the following criteria: purpose clearly stated; literature review relevant; research design appropriate to answer aims; no bias introduced into study; sample described in detail; sample size justified; informed consent gained; reliable outcome measures used; validated outcome measures used; intervention described in detail; results reported in terms of significance; analysis appropriate; clinical importance reported; conclusions appropriate; clinical implications reported; acknowledgement of limitations of the study.

      Results

      Three systematic reviews on the topic of management of DP were published in the past decade (Bialocerkowski et al., 2005;
      • Robinson S.
      • Proctor M.
      Diagnosis and management of deformational plagiocephaly.
      ,
      • Xia J.J.
      • Kennedy K.A.
      • Teichgraeber J.F.
      • Wu K.Q.
      • Baumgartner J.B.
      • Gateno J.
      Nonsurgical treatment of deformational plagiocephaly: A systematic review.
      ). We included studies that were reviewed by those authors to present a comprehensive set of studies in the past decade, and because our review focused on synthesizing the evidence in order to guide clinical decision making in primary care. The primary limitations of studies identified by Bialocerkowski and colleagues were moderate to poor quality of studies and the absence of a criterion standard measure to quantify skull asymmetry. Robinson and Proctor and Xia and colleagues noted the absence of randomized controlled trials and methodological biases that affected the level of evidence. We found that the quantity, quality, and strength of evidence related to management of DP has increased in the past decade, as supported by the addition of evidence from two randomized controlled trials (
      • Hutchison B.L.
      • Stewart A.W.
      • De Chalain T.B.
      • Mitchell E.A.
      A randomized controlled trial of positioning treatments in infants with positional head shape deformities.
      ,
      • van Vlimmeren L.A.
      • van der Graaf Y.
      • Boere-Boonekamp M.M.
      • L’Hoir M.P.
      • Helders P.J.
      • Engelbert R.H.
      Effect of pediatric physical therapy on deformational plagiocephaly in children with positional preference: A randomized controlled trial.
      ) and increased quality of studies. A majority (20) of the 23 studies on management of DP focused on the efficacy of orthotic devices with or without repositioning and physical therapy. Thirteen of the studies we reviewed specifically addressed the issue of timing in terms of the outcomes of interventions for DP.

      Timing of Treatment

      Although most authors have suggested that studying the natural history of DP in a controlled trial would not be feasible, one study (
      • van Vlimmeren L.A.
      • van der Graaf Y.
      • Boere-Boonekamp M.M.
      • L’Hoir M.P.
      • Helders P.J.
      • Engelbert R.H.
      Effect of pediatric physical therapy on deformational plagiocephaly in children with positional preference: A randomized controlled trial.
      ) compared a treatment group with a group of infants randomly assigned to receive usual care; the remainder of the studies that addressed timing of treatment compared two types of treatment using a case-control or cohort design. The van Vlimmeren study received a score of 16 out of a possible 16 points using the tool by

      Law, M., Stewart, D., Pollock, N., Letts, L., Bosch, J., & Westmorland, M. (1998). Critical review form: Quantitative studies. Retrieved from http://www.srs-mcmaster.ca/Portals/20/pdf/ebp/quanguidelines.pdf

      , which was the highest quality score for any of the 26 studies we reviewed. van Vlimmeren and colleagues implemented an intervention with infants younger than 6 months with DP and positional preference. The intervention was a standardized protocol of repositioning and physical therapy; after the intervention, the proportion of infants with severe DP in the intervention group was significantly lower than in the usual care group. The investigators also found that positional preference resolved for all infants in both groups by the age of 12 months. This finding suggests that with no intervention, some young infants with positional preference and DP may progress to severe DP even though positional preference resolves by the age of 1 year.
      There is general consensus that with current conservative therapies, a majority of cases of deformational plagiocephaly will have resolved by 2 years of age (
      • Hutchison B.L.
      • Hutchison L.A.
      • Thompson J.M.
      • Mitchell E.A.
      Plagiocephaly and brachycephaly in the first two years of life: A prospective cohort study.
      ). The evidence related to timing of treatment is limited for three reasons. First, treatment decisions are dependent on severity, leading to some variation in outcomes that is independent on timing of treatment (
      • de Ribaupierre S.
      • Vernet O.
      • Rilliet B.
      • Cavin B.
      • Kalina D.
      • Leyvraz P.F.
      Posterior positional plagiocephaly treated with cranial remodeling orthosis.
      ,
      • Graham Jr., J.M.
      • Gomez M.
      • Halberg A.
      • Earl D.L.
      • Kreutzman J.T.
      • Cui J.
      • Guo X.
      Management of deformational plagiocephaly: Repositioning versus orthotic therapy.
      ). Second, most infants who are treated with helmet therapy have had repositioning and physical therapy for varying degrees of time prior to orthotic management. Third, devices vary in terms of treatment duration, mechanism of pressure application, and type (e.g.,
      • Carson B.S.
      • Munoz D.
      • Gross G.
      • VanderKolk C.A.
      • James C.S.
      • Gates J.
      • Guarnieri M.
      • et al.
      An assistive device for the treatment of positional plagiocephaly.
      ,
      • Hutchison B.L.
      • Stewart A.W.
      • De Chalain T.B.
      • Mitchell E.A.
      A randomized controlled trial of positioning treatments in infants with positional head shape deformities.
      ,
      • Jalaluddin M.
      • Moss D.S.
      • Shafron D.H.
      Occipital plagiocephaly: The treatment of choice.
      ). The cohort studies in our review that addressed the timing of treatment were generally consistent in suggesting that earlier treatment is more effective than later treatment. Infants managed with positioning and physical therapies have a high rate of improvement, which continues as the child ages (
      • Hutchison B.L.
      • Stewart A.W.
      • Mitchell E.A.
      Deformational plagiocephaly: A follow-up of head shape, parental concern and neurodevelopment at ages 3 and 4 years.
      ). In their longitudinal cohort study of infants with deformational plagiocephaly,
      • Hutchison B.L.
      • Stewart A.W.
      • Mitchell E.A.
      Deformational plagiocephaly: A follow-up of head shape, parental concern and neurodevelopment at ages 3 and 4 years.
      found that 87% of preschoolers who had deformational plagiocephaly as infants had “good improvement” over time; 61% improved enough to have no clinical diagnosis of plagiocephaly by age 3 to 5 years. Brachycephaly improved more than plagiocephaly over time. Children with poor improvement in head shape and development tended to be those with the most severe DP in infancy, despite no difference in delays initially.

      Repositioning

      The most conservative intervention for infants with DP is also the recommended strategy for preventing DP: positioning the infant to minimize pressure on the back of the head (
      • Persing J.
      • James H.
      • Swanson J.
      • Kattwinkel J.
      American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery
      Prevention and management of positional skull deformities in infants.
      ). During the newborn period, parents should be counseled to lay the infant in alternating supine positions by the 2- to 4-week age period when the skull is maximally deformable (
      • Persing J.
      • James H.
      • Swanson J.
      • Kattwinkel J.
      American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery
      Prevention and management of positional skull deformities in infants.
      ).
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      suggest that the treatment of choice for infants up to 3 months of age with DP is early repositioning. If torticollis is involved, conservative treatment with physical therapy is effective if the infant presents before 3 months of age (
      • Graham Jr., J.M.
      • Gomez M.
      • Halberg A.
      • Earl D.L.
      • Kreutzman J.T.
      • Cui J.
      • Guo X.
      Management of deformational plagiocephaly: Repositioning versus orthotic therapy.
      ).
      Twelve of the studies we reviewed used positioning therapy with or without physical therapy as an intervention for infants with DP (Table 2). Lack of time in a prone position while awake for play has been shown to be associated with lower developmental scores at 6 months of age (
      • Monson R.M.
      • Deitz J.
      • Kartin D.
      The relationship between awake positioning and motor performance among infants who slept supine.
      ).When the AAP updated its Back to Sleep policy in 1996, they noted a possible association between supine sleep position and positional plagiocephaly. In 1996 the AAP recommended “a certain amount of ‘tummy time’ while the infant is awake and observed” for developmental reasons and to prevent flat spots on the occiput (
      American Academy of Pediatrics Task Force on Infant Positioning and SIDS
      Positioning and SIDS: Update.
      ). Healthy Child Care America, with the AAP, publishes a pamphlet for parents (“Back to Sleep, Tummy to Play,” www.healthychildcare.org) to explain the benefits of tummy time, the risks of prone sleeping, and activities to prevent a “flat head” (

      Healthy Child America & American Academy of Pediatrics, 2008 Healthy Child America & American Academy of Pediatrics. (2008). Back to sleep, tummy to play. Retrieved from www.healthychildcare.org/

      ).
      Despite publications for parents and Web sites related to parenting, parents and providers report a number of barriers to providing tummy time for infants (
      • Koren A.
      • Reece S.M.
      • Kahn-D’angelo L.
      • Medeiros D.
      Parental information and behaviors and provider practices related to tummy time and back to sleep.
      ). Provider barriers include confusion regarding the AAP guidelines, time limitations, and fear of legal implications (with prevention of sudden infant death syndrome emphasized as a priority over tummy time). Parent barriers include fear of sudden infant death syndrome, cultural differences in parenting, and confusion over the AAP guidelines (
      • Koren A.
      • Reece S.M.
      • Kahn-D’angelo L.
      • Medeiros D.
      Parental information and behaviors and provider practices related to tummy time and back to sleep.
      ). Providers can effect change in tummy time practice by understanding the specific guidelines and clarifying these for parents as well as relating to parents the importance of tummy time for normal infant development. The Box provides an overview of guidelines for parents regarding positioning and tummy time.
      Strategies for prevention and management of deformational plagiocephaly

      Repositioning Therapy

        Prevention

      • Alternate head position (left and right occipital areas) when lying infant down to sleep in the supine position
      • Infants should spend minimal time in car seats (or other devices that promote supine positions)
      • Use tummy time while supervised; if infant resists, start with just a minute or two and gradually increase as much as possible, with a goal of at least 30 minutes a day

        Counterpositioning

      • Prevention activities listed above, plus:
      • Active repositioning during sleep and play: place the rounded part of the infant’s head against the mattress (opposite to the infant’s preferred position)
      • Position the crib so that the infant’s head turns opposite the preferred position to view the room, (and/or alternate which end of the crib the infant is placed to sleep)
      • When using the changing table, alternate the end of the table at which the infant’s head is placed
      • Place toys on the side of the head where neck rotation is limited to encourage rotation in the non-preferred direction

      Neck Stretching Exercises for Infants With Torticollisa

      • Neck exercises should be done with each diaper change
      • Repeat each exercise three times (this should take about 2 additional minutes per diaper change):
        • Place one hand on the infant’s upper chest and use the other hand to gently rotate the infant’s head so that the chin touches the shoulder; hold for 10 seconds on each side
        • Tilt the head to the side, holding the head so that the ear approaches the shoulder; hold for 10 seconds on each side
      • Rotating chair or stool technique, for infants older than 3 months
        • Have the parent face the infant while another person holds the infant on his or her lap in a rotating chair or stool. The person holding the infant rotates 90 degrees, to the right and left, while the infant attempts to remain fixed on the parent
      • Refer to physical therapy for additional evaluation and treatment
      In active counter-positioning, parents are guided to position the baby “back to sleep” with instructions to reposition the infant by turning the infant’s head to the side opposite of the occipital flattening (
      • Steinbok P.
      • Lam D.
      • Singh S.
      • Mortenson P.A.
      • Singhal A.
      Long-term outcome of infants with positional occipital plagiocephaly.
      ). Neck exercises also can be helpful, especially when torticollis exists (
      • Do T.T.
      Congenital muscular torticollis: Current concepts and review of treatment.
      ,
      • van Vlimmeren L.A.
      • Helders P.J.
      • van Adrichem L.N.
      • Engelbert R.H.
      Torticollis and plagiocephaly in infancy: Therapeutic strategies.
      ). According to the AAP, neck exercises should be done with each diaper change. These exercises include three repetitions per exercise and should take approximately 2 minutes per diaper change. The exercises include gently rotating the infant’s chin to each shoulder, and tilting the head so that the infant’s ear approaches the shoulder (
      • Persing J.
      • James H.
      • Swanson J.
      • Kattwinkel J.
      American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery
      Prevention and management of positional skull deformities in infants.
      ). Images of these exercises in a patient education handout are available at http://rtcoleman.com/Neck_Stretching_Exercises.pdf. In addition, if the torticollis does not improve with exercises within 2 to 3 months, a referral to a physical therapist may be initiated (
      • Persing J.
      • James H.
      • Swanson J.
      • Kattwinkel J.
      American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery
      Prevention and management of positional skull deformities in infants.
      ). Physical therapy helps to correct positional plagiocephaly. The aim of physical therapy is to provide education to parents and caregivers about DP and to teach them exercises that will correct the shortening of the sternocleidomastoid muscle (
      • Biggs W.S.
      Diagnosis and management of positional head deformity.
      ).

      Orthotic (Helmet) Therapy

      Some infants with DP do not have significant improvement in head shape by 6 months despite conservative management (
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      ). The AAP suggests at least 6 to 8 weeks of repositioning therapy before considering orthotic therapy (
      • Najarian S.P.
      Infant cranial molding deformation and sleep position: Implications for primary care.
      ). Helmet therapy is a more intrusive method than the other conservative therapies. Cranial orthotics apply a “mild, dynamic pressure to the prominent regions of the skull—constraining growth in those areas, thereby encouraging growth in the flattened areas” (
      • Kelly K.M.
      • Littlefield T.R.
      • Pomatto J.K.
      • Manwaring K.H.
      • Beals S.P.
      Cranial growth unrestricted during treatment of deformational plagiocephaly.
      , p. 194). There is general consensus that repositioning therapy is preferred over helmet therapy in patients younger than 4 months and in those who have mild or moderate asymmetry; helmet therapy may be appropriate for infants 6 months or older or for infants with severe asymmetry regardless of age. This consensus, however, is based on expert opinion and not on rigorously designed clinical trials (
      • Vles J.S.
      • Colla C.
      • Weber J.W.
      • Beuls E.
      • Wilmink J.
      • Kingma H.
      Helmet versus nonhelmet treatment in nonsynostotic positional posterior plagiocephaly.
      ). High-quality evidence demonstrating the effectiveness of cranial orthoses compared with repositioning therapy is lacking (
      • Bialocerkowski A.E.
      • Vladusic S.L.
      • Wei Ng C.
      Prevalence, risk factors, and natural history of positional plagiocephaly: A systematic review.
      ,
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      ).
      We reviewed 20 studies that measured outcomes of cranial device therapy for DP. Several studies used a custom cranial remodeling helmet designed to be worn 20 to 23.5 hours a day (
      • de Ribaupierre S.
      • Vernet O.
      • Rilliet B.
      • Cavin B.
      • Kalina D.
      • Leyvraz P.F.
      Posterior positional plagiocephaly treated with cranial remodeling orthosis.
      ,
      • Elwood E.T.
      • Petronio J.
      • Wood R.J.
      Parental satisfaction with the CranioCap: A new cranial orthosis for deformational plagiocephaly.
      ,
      • Lennartsson F.
      Developing guidelines for child health care nurses to prevent nonsynostotic plagiocephaly: Searching for the evidence.
      ,
      • Losee J.E.
      • Mason A.C.
      • Dudas J.
      • Hua L.B.
      • Mooney M.P.
      Nonsynostotic occipital plagiocephaly: Factors impacting onset, treatment, and outcomes.
      ,
      • Teichgraeber J.F.
      • Ault J.K.
      • Baumgartner J.
      • Waller A.
      • Messersmith M.
      • Gateno J.
      • Xia J.
      • et al.
      Deformational posterior plagiocephaly: Diagnosis and treatment.
      ,
      • van Vlimmeren L.A.
      • van der Graaf Y.
      • Boere-Boonekamp M.M.
      • L’Hoir M.P.
      • Helders P.J.
      • Engelbert R.H.
      Effect of pediatric physical therapy on deformational plagiocephaly in children with positional preference: A randomized controlled trial.
      ).
      • Lee R.P.
      • Teichgraeber J.F.
      • Baumgartner J.E.
      • Waller A.L.
      • English J.D.
      • Lasky R.E.
      • Xia J.J.
      • et al.
      Long-term treatment effectiveness of molding helmet therapy in the correction of posterior deformational plagiocephaly: A five-year follow-up.
      used a pneumatic molding helmet designed to be worn 8 to 10 hours a day. Other devices included a generic helmet (not custom molded), which was designed to be used for children between 6 and 12 months of age (
      • Terpenning J.F.
      Static orthotic cranioplasty as a nonsurgical alternative for the treatment of deformational plagiocephaly.
      ); a positioning wrap designed to be worn only during sleep (
      • Hutchison B.L.
      • Stewart A.W.
      • De Chalain T.B.
      • Mitchell E.A.
      A randomized controlled trial of positioning treatments in infants with positional head shape deformities.
      ); and a cranial cup for infants younger than 4 months that was designed to be used while the infant is resting in the supine position (
      • Robinson S.
      • Proctor M.
      Diagnosis and management of deformational plagiocephaly.
      ). Several authors did not describe the protocol for wearing the device in detail (
      • Govaert B.
      • Michels A.
      • Colla C.
      • van der Hulst R.
      Molding therapy of positional plagiocephaly: Subjective outcome and quality of life.
      ,
      • Graham Jr., J.M.
      • Gomez M.
      • Halberg A.
      • Earl D.L.
      • Kreutzman J.T.
      • Cui J.
      • Guo X.
      Management of deformational plagiocephaly: Repositioning versus orthotic therapy.
      ,
      • Graham Jr., J.M.
      • Kreutzman J.
      • Earl D.
      • Halberg A.
      • Samayoa C.
      • Guo X.
      Deformational brachycephaly in supine-sleeping infants.
      ,
      • Hutchison B.L.
      • Stewart A.W.
      • Mitchell E.A.
      Deformational plagiocephaly: A follow-up of head shape, parental concern and neurodevelopment at ages 3 and 4 years.
      ,
      • Lee R.P.
      • Teichgraeber J.F.
      • Baumgartner J.E.
      • Waller A.L.
      • English J.D.
      • Lasky R.E.
      • Xia J.J.
      • et al.
      Long-term treatment effectiveness of molding helmet therapy in the correction of posterior deformational plagiocephaly: A five-year follow-up.
      ,
      • Looman W.S.
      • Flannery A.B.K.
      Evidence-based care of the child with deformational plagiocephaly, part I: Assessment and diagnosis.
      ,
      • Persing J.
      • James H.
      • Swanson J.
      • Kattwinkel J.
      American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery
      Prevention and management of positional skull deformities in infants.
      ,
      • Rogers G.F.
      • Miller J.
      • Mulliken J.B.
      Comparison of a modifiable cranial cup versus repositioning and cervical stretching for the early correction of deformational posterior plagiocephaly.
      ,
      • Steinbok P.
      • Lam D.
      • Singh S.
      • Mortenson P.A.
      • Singhal A.
      Long-term outcome of infants with positional occipital plagiocephaly.
      ,
      • Terpenning J.F.
      Static orthotic cranioplasty as a nonsurgical alternative for the treatment of deformational plagiocephaly.
      ).
      The evidence suggests that children may benefit from helmet therapy for severe DP that is refractive to conservative management by the age of 6 months (
      • Looman W.S.
      • Flannery A.B.K.
      Evidence-based care of the child with deformational plagiocephaly, part I: Assessment and diagnosis.
      ,
      • Persing J.
      • James H.
      • Swanson J.
      • Kattwinkel J.
      American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery
      Prevention and management of positional skull deformities in infants.
      ,
      • Terpenning J.F.
      Static orthotic cranioplasty as a nonsurgical alternative for the treatment of deformational plagiocephaly.
      ,
      • Vles J.S.
      • Colla C.
      • Weber J.W.
      • Beuls E.
      • Wilmink J.
      • Kingma H.
      Helmet versus nonhelmet treatment in nonsynostotic positional posterior plagiocephaly.
      ). Improvements from cranial molding helmets can be seen after the first several weeks, and most correction will occur by 3 months (
      • Hutchison B.L.
      • Stewart A.W.
      • De Chalain T.B.
      • Mitchell E.A.
      A randomized controlled trial of positioning treatments in infants with positional head shape deformities.
      ,
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      ). Because 85% of cranial growth occurs in the first year (
      • Pollack I.F.
      • Losken H.W.
      • Fasick P.
      Diagnosis and management of posterior plagiocephaly.
      ) and the rate of cranial growth in the second year is significantly slower (
      • Kelly K.M.
      • Littlefield T.R.
      • Pomatto J.K.
      • Manwaring K.H.
      • Beals S.P.
      Cranial growth unrestricted during treatment of deformational plagiocephaly.
      ), cranial molding therapy is rarely used after the age of 1 year. None of the studies we reviewed described helmet use beyond the age of 16 months. Devices designed to be worn only during sleep are less effective after the infant is mobile (
      • Hutchison B.L.
      • Stewart A.W.
      • De Chalain T.B.
      • Mitchell E.A.
      A randomized controlled trial of positioning treatments in infants with positional head shape deformities.
      ,
      • Robinson S.
      • Proctor M.
      Diagnosis and management of deformational plagiocephaly.
      ). None of the studies we reviewed indicated that any harm is associated with the use of cranial molding therapy.
      Consideration must be given to cost and financial aspects of plagiocephaly treatment, because cranial orthoses can range in cost from $2000 to $4000 (

      Blue Cross Blue Shield. (2010). Helmets of headbands for infants with irregularly shaped heads. Retrieved from http://www.bcbst.com/learn/treatment-options/HelmetsHeadband.shtm

      ). Access to a cranial orthoses treatment by a third-party payer decreases some stress and concern about the treatment (
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      ). However,
      • McKinney C.M.
      • Cunningham M.L.
      • Holt V.L.
      • Leroux B.
      • Starr J.R.
      Characteristics of 2733 cases diagnosed with deformational plagiocephaly and changes in risk factors over time.
      note that helmet therapy often is not covered by insurance. In 1998 the Food and Drug Administration classified cranial orthoses as a class II medical device intended for infants with moderate to severe non-synostotic plagiocephaly from 3 to 18 months of age (
      • Littlefield T.R.
      • Kelly K.M.
      Deformational plagiocephaly: Recommendations for future research.
      ). After the Food and Drug Administration provides clearance of a device, it must face the higher standards set by the Center for Medicare and Medicaid Services. Once the Center for Medicare and Medicaid Services determines that products and services are covered, other third-party payers often adopt these decisions (
      • Lipira A.B.
      • Gordon S.
      • Darvann T.A.
      • Hermann N.V.
      • Van Pelt A.E.
      • Naidoo S.D.
      • Kane A.A.
      • et al.
      Helmet versus active repositioning for plagiocephaly: A three-dimensional analysis.
      ). As a consequence of many factors, cost has inflated, which has caused reluctance by third-party payers and Medicaid to cover the treatment (
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      ). Many insurance companies will continue to deny treatment until functional problems are documented, on the basis that plagiocephaly is a cosmetic issue (
      • Lipira A.B.
      • Gordon S.
      • Darvann T.A.
      • Hermann N.V.
      • Van Pelt A.E.
      • Naidoo S.D.
      • Kane A.A.
      • et al.
      Helmet versus active repositioning for plagiocephaly: A three-dimensional analysis.
      ). This situation highlights the importance of the practitioner’s documentation of a full assessment that includes the presence of any functional problems.

      Surgery

      Surgery is rarely indicated for DP. If the skull is refractory to therapeutic physical adjustments and position changes, or if craniosynostosis is present, surgery may be indicated (
      • Najarian S.P.
      Infant cranial molding deformation and sleep position: Implications for primary care.
      ). Surgical management of plagiocephaly is indicated only in very severe cases, and even in these cases, correction may be minimal.
      • Loveday B.P.
      • de Chalain T.B.
      Active counterpositioning or orthotic device to treat positional plagiocephaly?.
      studied long-term outcomes of infants with DP treated surgically after the age of 15 months and report inconsistent outcomes and a relatively high rate of complications, including dural tears and venous sinus breaches.
      • David D.J.
      • Menard R.M.
      Occipital plagiocephaly.
      reported that two infants who underwent surgery for severe DP had no notable improvement by parent report. Early management is therefore essential, and for infants with severe DP, referral for specialty management is indicated.

      Referrals and Collaborative Management

      Collaborative management of moderate persistent or severe deformational plagiocephaly best serves children and families. Specialists with expertise in craniofacial disorders include pediatric neurosurgeons, pediatric plastic surgeons, and pediatric craniofacial team clinics (
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      ). Unlike subspecialty care, which provides condition-specific care, primary care is the point of access to the health care system, provides care over time, and coordinates care provided by others in the system (

      Antonelli, R., Stille, C, & Freeman, L. (2005). Enhancing collaboration between primary and subspecialty care providers for children and youth with special health care needs. Retrieved from http://gucchd.georgetown.edu/products/PrimarySpecialityCollaboration.pdf

      ). Comanagement of conditions such as DP can take three general forms: shared management; principal care of the condition may be managed by a specialist; or principal care of the condition may be managed by the primary care provider after initial evaluation and treatment planning with the specialist (

      American College of Physicians. (2010). The patient-centered medical home neighbor: The interface of the patient centered medical home with specialty/subspecialty practices (Policy Paper). Retrieved from http://www.acponline.org/advocacy/where_we_stand/policy/pcmh_neighbors.pdf

      ).
      For mild DP, the shared management model may be the most appropriate model of care. In the shared model, specialists provide expert advice and guidance for follow-up, while the primary care provider manages the condition on a day-to-day basis (

      Antonelli, R., Stille, C, & Freeman, L. (2005). Enhancing collaboration between primary and subspecialty care providers for children and youth with special health care needs. Retrieved from http://gucchd.georgetown.edu/products/PrimarySpecialityCollaboration.pdf

      ). For moderate persistent or severe DP that is not responsive to conservative management strategies, the second model of care may be most appropriate. In this model, the specialist manages the DP while the primary care provider continues to provide routine care and monitoring of growth and development, with continued communication with the specialist as appropriate. In some cases, the third model may best serve the child and family. In this model, principal care of DP is managed by the primary care provider after initial evaluation and treatment planning with the specialist; the primary care provider retains input on secondary referrals and may continue to provide specific aspects of the care. This model may be appropriate when helmet therapy is declined or used for a period of time, or when there is a coexisting developmental delay and/or torticollis that requires additional subspecialty care. The benefits of a collaborative model include less redundancy, greater efficiency, cost-effectiveness, more appropriate use of provider expertise, and care that is family centered (

      Antonelli, R., Stille, C, & Freeman, L. (2005). Enhancing collaboration between primary and subspecialty care providers for children and youth with special health care needs. Retrieved from http://gucchd.georgetown.edu/products/PrimarySpecialityCollaboration.pdf

      ).
      In any model of care, families should be partners in the team and their input should be included from the beginning. It is important to assess the degree to which the parents perceive their child’s head shape as acceptable and to determine the family goals of treatment. Parents of infants with asymmetric head shape report concerns regarding the infant’s appearance, its potential effect on the child’s future, and whether placing the child in the supine position to sleep makes them somehow accountable for the child’s abnormal head shape (
      • Collett B.
      • Breiger D.
      • King D.
      • Cunningham M.
      • Speltz M.
      Neurodevelopmental implications of “deformational” plagiocephaly.
      ,
      • Lee W.T.
      • Richards K.
      • Redhed J.
      • Papay F.A.
      A pneumatic orthotic cranial molding helmet for correcting positional plagiocephaly.
      ). Parents should be included in the decision-making process because the treatments, whether conservative or entailing the use of cranial orthoses, require significant caregiver involvement (
      • Bialocerkowski A.E.
      • Vladusic S.L.
      • Wei Ng C.
      Prevalence, risk factors, and natural history of positional plagiocephaly: A systematic review.
      ).

      Evaluation of Outcomes

      Progress and response to treatment in patients with DP requires routine follow-up and reassessment of the infant’s head shape, as well as evaluation of development and assessment for torticollis. Repeat measurements (by the same provider if possible) should be documented in the patient’s record. The degree of improvement can be determined by a change (or lack of change) in severity level and may include subjective appraisals of cosmetic appearance (
      • Losee J.E.
      • Mason A.C.
      Deformational plagiocephaly: Diagnosis, prevention, and treatment.
      ). Parental input should be part of every reassessment as well.
      Follow-up studies of children with a history of DP suggest that the condition affects long-term quality of life only in a small percentage of children (e.g.,
      • Govaert B.
      • Michels A.
      • Colla C.
      • van der Hulst R.
      Molding therapy of positional plagiocephaly: Subjective outcome and quality of life.
      ,
      • Plank L.H.
      • Giavedoni B.
      • Lombardo J.R.
      • Geil M.D.
      • Reisner A.
      Comparison of infant head shape changes in deformational plagiocephaly following treatment with a cranial remolding orthosis using a noninvasive laser shape digitizer.
      ,
      • Rogers G.F.
      • Miller J.
      • Mulliken J.B.
      Comparison of a modifiable cranial cup versus repositioning and cervical stretching for the early correction of deformational posterior plagiocephaly.
      ). The study by
      • Rogers G.F.
      • Miller J.
      • Mulliken J.B.
      Comparison of a modifiable cranial cup versus repositioning and cervical stretching for the early correction of deformational posterior plagiocephaly.
      examined parents’ and children’s perspectives of cosmetic appearance, noting that at 5 years there was “no or minimal concern about any residual plagiocephaly on the part of the child or parents” (p. 1280). Parent and child perceptions of long-term outcomes were not different based on orthotic use or conservative management. This finding is consistent with a study of 200 children with DP by

      Healthy Child America & American Academy of Pediatrics, 2008 Healthy Child America & American Academy of Pediatrics. (2008). Back to sleep, tummy to play. Retrieved from www.healthychildcare.org/

      , who noted that no parent expressed concern about their child’s head shape at 24 months of age.
      • Hutchison B.L.
      • Stewart A.W.
      • De Chalain T.B.
      • Mitchell E.A.
      A randomized controlled trial of positioning treatments in infants with positional head shape deformities.
      reported that most cases of DP improve by the age of 3 to 5 years, with a majority returning to normal range, and an incidence of developmental delays no higher than what might be expected in the normal population.

      Clinical Decision Tool for Management of DP

      Based on the review of evidence on management of DP, we developed a clinical decision tool (Figure) to guide the practitioner in assessing, diagnosing, and collaboratively managing the child with an asymmetric head. The tool also incorporates severity ratings based on our review of literature described in part I of this two-part series (see Table 3 in
      • Littlefield T.R.
      Food and drug administration regulation of orthotic cranioplasty.
      , 2012, p. 248). The primary care provider is encouraged to consult with a craniofacial clinic for any infant with head asymmetry who has an unclear diagnosis, for severe asymmetry, or for moderate to severe asymmetry that is refractory to repositioning treatment after the age of 4 to 6 months. When craniosynostosis is suspected, imaging may be indicated. Similarly, when torticollis and/or positional preference are noted, referral to physical therapy will facilitate evaluation and treatment as needed.
      Assessment and management of the infant with DP is convenient for the infant who is scheduled for regular well baby checks. Assessment of any infant presenting with asymmetric head shape should include a developmental screen and neurological examination. Regardless of the age of the infant, tummy time and repositioning strategies are indicated for all infants with positional preference or head asymmetry. For the infant with non-synostotic DP who is 2 months of age or younger, reassurance and parent education on positioning is recommended for mild, moderate, and severe DP (
      • Najarian S.P.
      Infant cranial molding deformation and sleep position: Implications for primary care.
      ), with referrals as appropriate. Family input is important to determine how parents and caregivers perceive the asymmetry. If head asymmetry remains when the infant is 6 months of age, monitoring should be more frequent because decisions regarding cranial remolding treatment are best made by 6 months of age. For mild to moderate DP at 4 months of age, repositioning and tummy time is still appropriate, with reassessment in 1 month. At that point, the infant with no improvement (based on anthropometric and visual assessments as described in part I) should be referred for consideration of cranial molding (helmet) therapy. For the infant with mild asymmetry at 6 to 9 months of age, cranial remolding therapy is not indicated. It is important to continue discussion with the family regarding their perception of the asymmetry and their goals related to the cosmetic outcome for the infant.

      Conclusions

      For parents who wish to pursue cranial molding therapy, there is no evidence of harm from this intervention, and the likelihood of success is high if treatment begins by 6 months of age.
      Management of deformational plagiocephaly depends on the age of the infant and the degree of head asymmetry. We believe the use of the clinical decision tool will facilitate evidence-based, family-centered practice in the management of the infant with DP. The consistency and quality of evidence related to conservative management of DP is improving over time with the addition of randomized controlled trials and more rigorously designed studies. This evidence indicates that DP is primarily a cosmetic concern in terms of long-term outcomes, but conservative management strategies can minimize the degree of asymmetry if they are implemented early. Early and continued assessment of infant development is essential. For parents who wish to pursue cranial molding therapy, there is no evidence of harm from this intervention, and the likelihood of success is high if treatment begins by 6 months of age. The cost of treatment can be high and may not be covered by insurance. Although management of moderate persistent or severe DP is appropriately managed collaboratively with specialty teams, primary care providers remain the family’s resource for ongoing assessment of a child’s growth and development. Prevention and management of early signs of head asymmetry are best achieved in a primary care setting, where the practitioner encounters infants on a schedule of well-child visits and changes over time can be recognized.

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      Biography

      Amanda B. Kack Flannery, Pediatric Nurse Practitioner, School of Nursing, University of Minnesota, Minneapolis, MN.
      Wendy S. Looman, Associate Professor and Pediatric Nurse Practitioner, School of Nursing, University of Minnesota, Minneapolis, MN.
      Kristin Kemper, Pediatric Nurse Practitioner, Cleft and Craniofacial Clinics, Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN.