HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial

Background In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls) aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. Methods/design Pragmatic randomised controlled trial (RCT) nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment). At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT); they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined. Discussion HEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies. Besides these health outcomes, we will be able to address several methodological questions, e.g. do participants in an RCT represent the eligible target population and do outcomes of the RCT differ from outcomes found in the nRCT

Asymmetry in infancy : The effect of paediatric physical therapy on the course of deformational plagiocephaly and subsequent developmental delay

Epidemiological studies have shown that prone and side sleeping is a major risk for Sudden Infant Death Syndrome. Since the early nineties, concurrent with the increase in supine sleeping, consistent with the American Academy of Pediatrics recommendations that healthy term infants should be positioned on their side or back to sleep, a rise in the prevalence of positional preference and deformational plagiocephaly has been observed. We presented a clinical flow chart showing different pathways in therapeutic strategies such as physical therapy, orthotic devices and surgery on the most occurring asymmetries in infancy (congenital muscular torticollis, positional torticollis and plagiocephaly) , based on best available evidence in current literature, in order to achieve uniformity in therapeutic thinking and performance. We investigated the psychometrical aspects of plagiocephalometry, a new instrument to assess and quantify the asymmetry of the skull. Using a thermoplastic material to mould the outline of the infant's skull, a reproduction of the skull shape is performed on paper allowing for accurate cephalometric measurements. We concluded that plagiocephalometry is an easy-to-apply, non-invasive, reliable and valid method to assess skull asymmetry with good clinical use and low application costs. Plagiocephalometry might serve as an instrument used in all levels of care for children with deformational plagiocephaly and might, by measurements over time, provide information concerning the natural course of deformational plagiocephaly as well as the assessment of the effects of conservative treatment strategies. We documented the prevalence of positional preference and deformational plagiocephaly at birth. We also studied prevalence changes over time until the age of seven weeks, and we identified risk factors that influence the occurrence and possible progression of deformational plagiocephaly. Three determinants were associated with an increased risk of deformational plagiocephaly at birth: male gender, birth rank first-born and brachycephaly. Deformational plagiocephaly at birth is not a predictor for deformational plagiocephaly at seven weeks of age. Deformational plagiocephaly at seven weeks of age was primarily caused by postnatal, external factors (nursing habits, positioning and care). Earlier achievement of motor milestones protects the child from developing deformational plagiocephaly. No significant association was found between supine sleeping and the development of positional preference and deformational plagiocephaly. A persistent restriction of the range of joint motion of the cervical spine associated with deformational plagiocephaly was not found. We investigated the effectiveness of a standardized paediatric physical therapy protocol on the occurrence and the course of positional preference and severe deformational plagiocephaly, assessed at seven weeks after birth (entry of the study) and at the age of six and twelve months. A four-month standardized paediatric physical therapy intervention program on children with positional preference significantly reduced the prevalence of severe deformational plagiocephaly compared to usual care. For children with deformational plagiocephaly and their parents, a careful multidisciplinary assessment and follow up program in child health care centres and paediatric physical therapy practices, based on updated protocols, clinical guidelines regarding positioning, handling and training of children with positional preference and with or without deformational plagiocephaly, are highly recommendable

Helmbehandeling bij zuigelingen met positionele schedelvervorming

In Nederland droegen in het afgelopen decennium jaarlijks zo’n tweeduizend baby’s maandenlang een helm om schedelvervorming te corrigeren, terwijl de effectiviteit van deze behandeling niet was aangetoond. In de heads-studie zijn 84 gezonde baby’s met matige tot ernstige schedelvervorming op de leeftijd van 5 à 6 maanden ‘at random’ verdeeld: 42 baby’s kregen helmbehandeling en bij 42 baby’s werd het natuurlijke beloop afgewacht. Uit de resultaten bleek dat de helmbehandeling geen toegevoegde waarde heeft ten opzichte van het afwachten van het natuurlijke beloop bij schedelvervorming. Aangezien de helm veel bijwerkingen geeft en de therapiekosten hoog zijn, wordt het gebruik hiervan afgeraden bij gezonde zuigelingen van 5 à 6 maanden oud met matige tot ernstige schedelvervorming. Het accent van de aanpak van voorkeurshouding en (beginnende) schedelvervorming bij baby’s moet (nog) meer komen te liggen op de preventieve adviezen van de kraamzorg en de jeugdgezondheidszorg en op vroegtijdige opsporing, eventueel gevolgd door tijdige verwijzing naar de kinderfysiotherapeut

The course of skull deformation from birth to 5 years of age: a prospective cohort study

Contains fulltext : 170094.pdf (publisher's version ) (Open Access)In a continuation of a prospective longitudinal cohort study in a healthy population on the course of skull shape from birth to 24 months, at 5 years of age, 248 children participated in a follow-up assessment using plagiocephalometry (ODDI-oblique diameter difference index, CPI-cranio proportional index). Data from the original study sampled at birth, 7 weeks, 6, 12, and 24 months were used in two linear mixed models. MAIN FINDINGS: (1) if deformational plagiocephaly (ODDI <104%) and/or positional preference at 7 weeks of age are absent, normal skull shape can be predicted at 5 years of age; (2) if positional preference occurs, ODDI is the highest at 7 weeks and decreases to a stable lowest value at 2 and 5 years of age; and (3) regarding brachycephaly, all children showed the highest CPI at 6 months of age with a gradual decrease over time. CONCLUSION: The course of skull deformation is favourable in most of the children in The Netherlands; at 5 years of age, brachycephaly is within the normal range for all children, whereas the severity of plagiocephaly is within the normal range in 80%, within the mild range in 19%, and within the moderate/severe range in 1%. Medical consumption may be reduced by providing early tailored counselling. What is Known: * Skull deformation prevalence increased after recommendations against Sudden Infant Death Syndrome, little is known about the longitudinal course. * Paediatric physical therapy intervention between 2 and 6 months of age reduces deformational plagiocephaly at 6 and 12 months of age. What is New: * The course of skull deformation is favourable in most of the children in The Netherlands; at 5 years of age, deformational brachycephaly is within the normal range for all children, whereas the severity of deformational plagiocephaly is within the normal range in 80%, within the mild range in 19%, and within the moderate to severe range in only 1%. * Paediatric physical therapy intervention does not influence the long-term outcome; it only influences the earlier decrease of the severity of deformational plagiocephaly