RecruitingACTRN12605000023651

The Treatment of Non-synostotic Plagiocephaly and Brachycephaly in Infants

A randomised, controlled trial to assess the effectiveness of positioning treatment to improve head shape measurements in infants with non-synostotic plagiocephaly and brachycephaly, using (1) in severe cases, either a sleep positioning wrap or a head positioning helmet, and (2) in mild to moderate cases, either education alone or education plus a sleep positioning wrap.


Sponsor

Professor Ed Mitchell, University of Auckland.

Enrollment

308 participants

Start Date

May 20, 2005

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 12 Monthss

Plain Language Summary

Simplified for easier understanding

This study looks at the best way to treat babies who have a flattened or asymmetrical head shape (called plagiocephaly or brachycephaly) that is not caused by the skull bones fusing too early. Researchers want to find out whether certain positioning techniques and helmets or other devices can help correct head shape in infants. You may be eligible if: - Your baby is under 12 months of age - Your baby has been diagnosed with non-synostotic plagiocephaly (flat head on one side) or brachycephaly (flat head at the back) You may NOT be eligible if: - Your baby has craniosynostosis (skull bones fused too early) - Your baby has congenital abnormalities - Your baby is older than 12 months - Your family lives outside the Auckland, Counties Manukau, or Waitemata District Health Board areas, or plans to move - Your baby is already using a Safe T Sleep sleep positioning device Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 o

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.


Locations(1)

New Zealand

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ACTRN12605000023651