Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000023651
Ethics application status
Approved
Date submitted
18/07/2005
Date registered
19/07/2005
Date last updated
19/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Treatment of Non-synostotic Plagiocephaly and Brachycephaly in Infants
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-synostotic plagiocephaly 85 0
Non-synostotic brachycephaly 86 0
Condition category
Condition code
Neurological 107 107 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 27 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 133 0
Head shape, specifically the change in cephalic index and oblique cranial length ratio.
Timepoint [1] 133 0
Measured 3, 6 and 12 months after initiation of treatment.
Secondary outcome [1] 295 0
For Group (2), a change in developmental score
Timepoint [1] 295 0
Between baseline and 12 months, using the Bayley Scales of Infant Development, 2nd Edition.

Eligibility
Key inclusion criteria
Any child under 12 months of age, and diagnosed with non-synostotic plagiocephaly or brachycephaly
Minimum age
0 Days
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed letter with ID on outside, prepared by person other than researcher, opened at the moment of assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random allocation of treatment to ID number. Each successive infant enrolled receives the next consecutive ID number.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
308
Accrual to date
Final
Recruitment outside Australia
Country [1] 125 0
New Zealand
State/province [1] 125 0

Funding & Sponsors
Funding source category [1] 141 0
Charities/Societies/Foundations
Name [1] 141 0
Child Health Research Foundation
Country [1] 141 0
New Zealand
Funding source category [2] 142 0
Charities/Societies/Foundations
Name [2] 142 0
Auckland Medical Research Foundation
Country [2] 142 0
New Zealand
Primary sponsor type
Individual
Name
Professor Ed Mitchell, University of Auckland.
Address
Country
New Zealand
Secondary sponsor category [1] 101 0
Individual
Name [1] 101 0
Dr Lynne Hutchison
Address [1] 101 0
Country [1] 101 0
Secondary sponsor category [2] 102 0
Individual
Name [2] 102 0
Dr Tristan de Chalain
Address [2] 102 0
Country [2] 102 0
Secondary sponsor category [3] 103 0
Individual
Name [3] 103 0
Mr Alistair Stewart
Address [3] 103 0
Country [3] 103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 887 0
Auckland Regional Ethics Committee
Ethics committee address [1] 887 0
Ethics committee country [1] 887 0
New Zealand
Date submitted for ethics approval [1] 887 0
Approval date [1] 887 0
Ethics approval number [1] 887 0
Ethics committee name [2] 888 0
Auckland District Health Board
Ethics committee address [2] 888 0
Ethics committee country [2] 888 0
New Zealand
Date submitted for ethics approval [2] 888 0
Approval date [2] 888 0
Ethics approval number [2] 888 0
Ethics committee name [3] 889 0
Counties Manukau District Health Board
Ethics committee address [3] 889 0
Ethics committee country [3] 889 0
New Zealand
Date submitted for ethics approval [3] 889 0
Approval date [3] 889 0
Ethics approval number [3] 889 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35860 0
Address 35860 0
Country 35860 0
Phone 35860 0
Fax 35860 0
Email 35860 0
Contact person for public queries
Name 9216 0
Dr Lynne Hutchison
Address 9216 0
Department of Paediatrics
University of Auckland
Private Bag 92019
Auckland 1
Country 9216 0
New Zealand
Phone 9216 0
+64 9 3737599 (Ext. 83979)
Fax 9216 0
+64 9 3737486
Email 9216 0
[email protected]
Contact person for scientific queries
Name 144 0
Professor Ed Mitchell
Address 144 0
Department of Paediatrics
University of Auckland
Private Bag 92019
Auckland 1
Country 144 0
New Zealand
Phone 144 0
+64 9 3737599 (Ext. 86431)
Fax 144 0
+64 9 3737486
Email 144 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.