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Trial registered on ANZCTR


Registration number
ACTRN12612000976886
Ethics application status
Approved
Date submitted
5/09/2012
Date registered
11/09/2012
Date last updated
11/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of an insert device for infant car seats aiming to improve infant oxygenation.
Scientific title
A randomised trial of an insert device for infant car seats aiming to improve infant oxygenation.
Secondary ID [1] 280987 0
n/a
Universal Trial Number (UTN)
U1111-1133-3208
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oxygen saturation 287108 0
apnoea 287109 0
obstructive sleep apnoea 287110 0
sleep 287111 0
infant behaviour 287112 0
infants in car seats 287113 0
Condition category
Condition code
Respiratory 287435 287435 0 0
Other respiratory disorders / diseases
Injuries and Accidents 287436 287436 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At 5 - 11 days age each infant was studied for one daytime sleep period (30 min to 3 hours duration) with polysomnogram recording, whilst seated in a standard car seat fitted with the foam plastic car seat insert device (fabric covered 2.5 cm thick foam 'H' shaped device with a slot cut in the top, the seat belt straps brought through the top slot and through a slim slot in the base)
Further to the sleep study the parents of infants were then asked to complete a 6 week diary of car seat use. They were required to state whether an insert was used during this time period.
Intervention code [1] 285433 0
Treatment: Devices
Intervention code [2] 285641 0
Prevention
Comparator / control treatment
At 5 -11 days age each control infant was studied with polysomnogram recorded for a daytime sleep in the standard car seat with no insert device.
Control group
Active

Outcomes
Primary outcome [1] 287699 0
Mean oxygen saturation in insert group vs controls over sleep period in car seat. This is assessed by recording sleep parameters using a Sandman Pocket 2008 device fitted with Nellcor pulse oximeter. Sleep was analyzed using Sandman Elite V software to enable mean oxygenation determination for each sleep.
Timepoint [1] 287699 0
30 min- 3 hours of sleep
Primary outcome [2] 287700 0
Mean low oxygen saturation in insert group vs controls. Oxygen saturation is assessed by recording sleep parameters using a Sandman Pocket 2008 device fitted with Nellcor pulse oximeter. Sleep was analyzed using Sandman Elite V software to enable haemoglobin oxygen desaturation events to be identified analyzed.
Timepoint [2] 287700 0
30 min-3 hours sleep
Primary outcome [3] 287701 0
Number of haemoglobin oxygen desaturation events ( > 4 % drop blood oxygen saturation for > or = to 10 seconds) in insert group vs controls. Desaturation events assessed by recording sleep parameters using a Sandman Pocket 2008 device fitted with Nellcor pulse oximeter. Sleep was analyzed using Sandman Elite V software to enable haemoglobin oxygen desaturation events to be identified analyzed.
Timepoint [3] 287701 0
30min - 3 hours sleep
Secondary outcome [1] 298655 0
Adverse events in car seats over a 6 week period recorded in a diary insert use vs no insert use. Examples of possible adverse events would be poor fit of the insert device in the car seat, apnea, cyanosis episodes in the car seat.
Timepoint [1] 298655 0
6 weeks
Secondary outcome [2] 298656 0
Periods of use of the car seat for infant travel vs a place of sleep or containment outside of the car over 6 weeks
Timepoint [2] 298656 0
6 weeks

Eligibility
Key inclusion criteria
full term ( 37-42 weeks gestation) newborn infants healthy at time of the sleep study study performed at 5-11 days from birth.
Minimum age
5 Days
Maximum age
11 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pre-maturity (<37 weeks gestation), any significant health concerns at recruitment

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 and infants were invited to take part in the study by their midwife or doctor. They were provided with a study information sheet. Once consent was obtained infants were randomised by opening of opaque sealed envelopes containing computer sequenced randomisation of insert or no insert during the sleep study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer sequenced randomisation printed on paper and sealed in sequentially numbered opaque envelopes.
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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
81
Accrual to date
Final
Recruitment outside Australia
Country [1] 4463 0
New Zealand
State/province [1] 4463 0
Auckland

Funding & Sponsors
Funding source category [1] 285770 0
Charities/Societies/Foundations
Name [1] 285770 0
Auckland Medical Research Foundation
Country [1] 285770 0
New Zealand
Funding source category [2] 285771 0
Charities/Societies/Foundations
Name [2] 285771 0
Cure Kids
Country [2] 285771 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] 284804 0
Charities/Societies/Foundations
Name [1] 284804 0
Cure Kids
Address [1] 284804 0
PO Box 90 907
Victoria Street West
Auckland 1142
Country [1] 284804 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287982 0
northern x ethics committee
Ethics committee address [1] 287982 0
Ethics committee country [1] 287982 0
Date submitted for ethics approval [1] 287982 0
Approval date [1] 287982 0
Ethics approval number [1] 287982 0

Summary
Brief summary
Infants are at risk of low oxygen levels and apparent life threatening events and even death whilst sleeping in infant car seats. A foam plastic insert was developed to improve the position of infants in car seats. Hypothesis: that the foam insert can prevent episodes of reduced oxygenation in infants in car seats. This study also quantified car seat use in the study group over a 6 week period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34547 0
Address 34547 0
Country 34547 0
Phone 34547 0
Fax 34547 0
Email 34547 0
Contact person for public queries
Name 17794 0
Dr Christine McIntosh
Address 17794 0
Dept. of Physiology,
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 17794 0
New Zealand
Phone 17794 0
+64211053144
Fax 17794 0
Email 17794 0
[email protected]
Contact person for scientific queries
Name 8722 0
Christine McIntosh
Address 8722 0
Dept. of Physiology,
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 8722 0
New Zealand
Phone 8722 0
+64211053144
Fax 8722 0
Email 8722 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
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Documents added automatically
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