The research question of the main study is: What are the short- and long-term effects and costs of helmet treatmentcompared to a wait-and-see regimen for a period of 6 months on skull asymmetry in children withmoderate to severe DP.The objective of…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the (a)symmetry of the skull at 8, 12, and 24 months,
measured
by PCM.
Secondary outcome
Secondary outcome of the main study:
- subjective outcome score;
- (psycho)motor development;
- quality of life;
- parental attitudes;
- parental anxiety level and parental concerns;
- satisfaction with the treatment.
Secondary outcome of the ancillary methods study:
- actual preference for treatment (randomisation, helmet, wait-and-see);
- Decisional Conflict Scale;
- stated preference for treatment.
Background 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 effectiveness of treatment has not been illustrated.
Study objective
The research question of the main study is: What are the short- and long-term
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.
The objective of the ancillary methods study is to assess preferences of
parents and professionals for treatment
characteristics and to study the relation with actual treatment choice,
clinical outcome and treatment satisfaction.
Study design
A randomised controlled trial into the effectiveness of helmet treatment,
nested in a follow-up study.
Intervention
Included children will be randomly assigned to either helmet treatment or a
wait-and-see
regimen, both for a period of 6 months.
Study burden and risks
- The child and his parents are not exposed to any specific risks.
- Helmet treatment has almost become regular treatment, although effectiveness
has not been illustrated in RCT's. Therefore the burden for patients is not
different from the current situation.
- At het age of 2-4, 5, 8, 12 and 24 months, the child is examined including
plagiocefalometry (PCM). These consultations will take about 30 minutes (PCM,
questionnaires). At the age of 2-4, 5, 8 and 12 months, the measurements are
linked to regular consultations of the pediatric physiotherapist and cost
relatively little extra time of parents. Furthermore, the consultations take
place at the practice location of the pediatric physiotherapist, close to the
residence of the parents.
Postbus 217
7500 AE Enschede
NL
Postbus 217
7500 AE Enschede
NL
Listed location countries
Age
Inclusion criteria
Infants in the age of 5-6 months with the following PCM inclusion criteria: plagiocephaly 108% <= ODDI <= 113, brachycephaly 95 <= CPI <= 104%, mixed forms according to adjusted criteria for ODDI and CPI.
Exclusion criteria
Premature children (< 37 weeks), children with congenital muscular torticollis, synostotic plagiocephaly and/or dysmorphisms
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN18473161 |
| CCMO | NL24352.044.08 |