None listed
Conditions
Interventions
Infants under the age of 12 months and diagnosed with non-synostotic plagiocephaly or brachycephaly are categorised as (1) severe or (2) mild-moderate, according to objective head shape measurements of cephalic index or oblique cranial length ratio. Group (1) is randomised to either a sleep positioning wrap or a head positioning helmet; Group (2) is randomised to education alone or education plus a sleep positioning wrap. Infants are followed up 3, 6, and 12 months after initiation of treatme
Infants under the age of 12 months and diagnosed with non-synostotic plagiocephaly or brachycephaly are categorised as (1) severe or (2) mild-moderate, according to objective head shape measurements of cephalic index or oblique cranial length ratio. Group (1) is randomised to either a sleep positioning wrap or a head positioning helmet; Group (2) is randomised to education alone or education plus a sleep positioning wrap. Infants are followed up 3, 6, and 12 months after initiation of treatment to assess the effectiveness of treatment.
Sponsors
Professor Ed Mitchell, University of Auckland.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 12 Months
Healthy volunteers
No
Inclusion criteria
Any child under 12 months of age, and diagnosed with non-synostotic plagiocephaly or brachycephaly
Exclusion criteria
Craniosynostosis, congenital abnomalities, older than 12 months, residing (or planning to move) outside Auckland, Counties Manukau, or Waitemata District Health Board areas, currently using a Safe T Sleep sleep positioning device.
Outcome results
None listed