Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000622000
Ethics application status
Not yet submitted
Date submitted
27/07/2010
Date registered
29/07/2010
Date last updated
29/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Are baby hammocks a safe place for baby to sleep in?
Scientific title
A randomised trial of infants sleeping in baby hammock vs cot to determine if there is a difference in oxygen desatuartion events and mean oxygen saturation.
Secondary ID [1] 252321 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep apnoea 257824 0
Sudden unexplained death in Infancy (SUDI) 257827 0
Condition category
Condition code
Respiratory 257995 257995 0 0
Sleep apnoea
Respiratory 257996 257996 0 0
Normal development and function of the respiratory system
Injuries and Accidents 257997 257997 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study of 30 babies aged 6-12 weeks age, randomised to either sleep in a commercially available hammock ( yet to be determined) or a standard type bassinete for 1 daytime nap ( approx 1-3 hours). Babies will have limited sleep studies recorded using Sandman Pocket Express (2008). Sleep studies will be analysed for sleep state, mean oxygen saturation, desatuartion events and respiratory events.
Intervention code [1] 256886 0
Prevention
Comparator / control treatment
Standard type bassinete/cot ( made specifically for Moe Ora scheme) for 1 daytime nap ( approx 1-3 hours). Babies will have limited sleep studies recorded using Sandman Pocket Express (2008). Sleep studies will be analysed for sleep state, mean oxygen saturation, desatuartion events and respiratory events.
Control group
Active

Outcomes
Primary outcome [1] 258857 0
number of episodes haemoglobin oxygen desaturation events measured by cutaneous oxygen sensor
Timepoint [1] 258857 0
one daytime sleep
Secondary outcome [1] 264982 0
mean haemoglobin oxygen saturation measured by cutaneous oxygen sensor
Timepoint [1] 264982 0
one daytime sleep

Eligibility
Key inclusion criteria
Healthy, normal full term infants
Minimum age
0 Days
Maximum age
12 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
requires oxygen treatment
infants with any current health problem
history of significant birth trauma

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
parents will be invited to allow their infant to participate in the study. Babies will be allocated to hammock or cot by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2788 0
New Zealand
State/province [1] 2788 0

Funding & Sponsors
Funding source category [1] 257349 0
University
Name [1] 257349 0
University of Auckland
Country [1] 257349 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Faculty of Medical and Health Sciences,
The University of Auckland,
Private Bag 92019,
Auckland 1023, New Zealand
Country
New Zealand
Secondary sponsor category [1] 256589 0
None
Name [1] 256589 0
Address [1] 256589 0
Country [1] 256589 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259371 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259371 0
3rd floor, Unisys building
650 Great South Rd
Penrose
Private Bag 92-522, Wellesley St
Auckland,
1141
Ethics committee country [1] 259371 0
New Zealand
Date submitted for ethics approval [1] 259371 0
27/08/2010
Approval date [1] 259371 0
Ethics approval number [1] 259371 0

Summary
Brief summary
There is now evidence that some young babies are at particular of risk of low oxygen levels in any position where their head is bent forward on to the chest. At this age the baby’s jaw is still very mobile, and any pressure on the jaw forces it backwards, narrowing and potentially blocking the upper airway. We have previously studied this effect when babies are restrained in car seats.

Baby hammocks are widely used because the gentle rocking helps the baby to sleep. However, their design tends to flex the baby forward, suggesting that these hammocks could potentially cause falls in baby blood oxygen levels.

This research will study babies during a daytime sleep in a safe monitored environment. They will either sleep in a cot or a hammock. This will help to determine if sleeping in a hammock causes breathing problems for babies compared to sleeping in a cot. It will provide valuable information on the safety of baby hammocks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31441 0
Address 31441 0
Country 31441 0
Phone 31441 0
Fax 31441 0
Email 31441 0
Contact person for public queries
Name 14688 0
Christine McIntosh
Address 14688 0
Department of Physiology,
Faculty of Medical and Health Sciences,
The University of Auckland,
Private Bag 92019,
Auckland 1023, New Zealand
Country 14688 0
New Zealand
Phone 14688 0
+64 211053144
Fax 14688 0
Email 14688 0
[email protected]
Contact person for scientific queries
Name 5616 0
Christine McIntosh
Address 5616 0
Department of Physiology,
Faculty of Medical and Health Sciences,
The University of Auckland,
Private Bag 92019,
Auckland 1023, New Zealand
Country 5616 0
New Zealand
Phone 5616 0
+64 211053144
Fax 5616 0
Email 5616 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.