|- candidate number||8184|
|- NTR Number||NTR2393|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-jun-2010|
|- Secondary IDs||ISRCTN18473161 / ZonMW80-82301-98-0909 / MEC NL24352.044.08|
|- Public Title||Onderzoek naar de effecten van helmbehandeling van kinderen van 5 maanden met een schedelvervorming.|
|- Scientific Title||Deformational plagiocephaly: Effects and costs of helmet treatment and a wait-and-see regimen.|
|- ACRONYM||HEADS study|
|- hypothesis||In comparison with a wait-and-see regimen, redression helmet treatment in infants with deformational plagiocephaly (DP) is more effective, measured subjectively with a Satisfaction Outcome Score and objectively with plagiocephalometry.
The hypothesis for the ancilliary HTA study is that parental stated preferences predict parental actual decision making.
|- Healt Condition(s) or Problem(s) studied||Skull deformation, Plagiocephaly, Brachycephaly, Helmet therapy, Positional preference|
|- Inclusion criteria||1. Children 5 months of age, either sex;|
2. Moderate to severe DP:
A. Plagiocephaly: 108% less than or equal to Oblique Diameter Difference Index (ODDI) less than or equal to 113%;
B. Brachycephaly: 95% less than or equal to Cranial Proportional Index (CPI) less than or equal to 104%;
C. Mixed forms according to adjusted criteria.
|- Exclusion criteria||1. Premature children;|
2. Children with congenital muscular torticollis;
5. Neurological dysfunctions.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2009|
|- planned closingdate||31-dec-2011|
|- Target number of participants||96|
|- Interventions||Included children will be randomly assigned to either helmet treatment or a wait-and-see regimen, both for a period of 6 months.
Helmet treatment initiated at the age of 5 months and supervised by a physician in one of the two specialised centres. A custom-made helmet is constructed by an orthotist and is made of mouldable plastic. The helmet is worn both day and night, for an average of four to six months.
Recovery of the deformation of the head is awaited by allowing spontaneous growth of the skull. Preceding physiotherapy will be discontinued.
|- Primary outcome||Symmetry of the skull at 8, 12, and 24 months, measured by plagiocephalometry (PCM). |
|- Secondary outcome||Main study:|
1. Subjective outcome score (at 5, 12, 24 months);
2. (Psycho)motor development (at 5, 12 and 24 months) (AIMS, Van Wiechen, ASQ);
3. Quality of life (at 2 years);
4. Parental attitudes (at 5, 12 and 24 months);
5. Parental anxiety level and parental concerns (at 5, 12 and 24 months) (STAI);
6. Satisfaction with the treatment (at 12 and 24 months).
Secondary outcome of the ancillary methods study:
1. Decisional conflict scale;
2. Actual preference for treatment (helmet, wait-and-see, randomised controlled trial [RCT]);
3. Stated preference for treatment.
|- Timepoints||8, 12, and 24 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. Renske M. Wijk, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Magda M. Boere-Boonekamp|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Deformational plagiocephaly/brachycephaly (together “DP”) refers to a condition in which the infant’s head - and possibly the face - are deformed as a result of prenatal and/or postnatal external forces to the malleable and growing cranium. This often leads to an asymmetric cranium, ear misalignment and facial asymmetry. When only the occiput is flattened (symmetrically), the condition is called brachycephaly. The number of children with DP treated with a helmet has risen dramatically in the past decade.
The research question of this study is: What are the effects and costs of helmet treatment compared to a wait-and-see regimen for a period of 6 months on skull asymmetry in children with moderate to severe DP.
RCT, nested in a follow-up study.
Infants 2-4 months of age with persistent positional preference and/or DP, referred by the youth health care physician for paediatric physiotherapy. Skull symmetry will be measured with plagiocephalometry (PCM) before treatment is started. Eligible children 5 months of age with moderate to severe DP (plagiocephaly: 108% <= ODDI <= 113; brachycephaly: 95 <= CPI <= 104%; mixed forms according to adjusted criteria) will be asked to articipate in the RCT. Premature children, children with congenital muscular torticollis, synostosis, dysmorphisms, neurological dysfunctions will be excluded. Parents of eligible children who prefer not to participate in the RCT will be invited for a follow-up program.
Included children will be randomly assigned to either helmet treatment or a wait-and-see regimen, both for a period of 6 months.
Primary outcome is the (a)symmetry of the skull at 8, 12, and 24 months, measured by PCM.
Secondary outcome: Subjective outcome score; (psycho)motor development, quality of life;
parental anxiety level, attitudes, concerns, satisfaction with the treatment.
Sample size for the RCT is calculated at 96 children, in order to be able to significantly demonstrate a difference in mean improvement of at least 4 ODDI-points between the helmet group and the wait-and-see group. Analysis on ‘intention-to-treat’ basis.
An economic evaluation from a societal viewpoint will be included.
|- Main changes (audit trail)|
|- RECORD||28-jun-2010 - 11-jul-2010|