Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000993099
Ethics application status
Approved
Date submitted
12/11/2010
Date registered
16/11/2010
Date last updated
9/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Kahungunu Infant Safe Sleep Study
Scientific title
The Kahungunu Infant Safe Sleep Study: A Randomised Controlled Trial of the use of the 'wahakura', a flax woven basket versus portable bassinet for the sleep of infants at risk of Sudden Unexpected Infant Death.
Secondary ID [1] 253077 0
HRC 10-477
Universal Trial Number (UTN)
U1111-1117-9460
Trial acronym
KISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden Unexpected Death in infancy 258641 0
Breast Feeding 258642 0
Condition category
Condition code
Public Health 258780 258780 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The wahakura is a 36x72cm flax bassinet, with no handles, and a 20mm thick foam sponge mattress covered in a cotton pillowcase. They are woven by local weavers, and supplied to the mother during the pregnancy, with some standard instructions. They are to be used for babies’ sleep, wherever and whenever they sleep, be it floor, mattress, bassinet, cot, or bed. When used in the bed situation, the wahakura should be used on top of the blankets. They should not be used in the car (car seat recommended), nor should babies be carried in them. They should be passed on to all carers (babysitter, grandparents, and extended whanau). Babies should sleep on their back, with no pillows, face always clear of blankets, no toys or loose objects in the wahakura. It is being tested because there is no evidence in the literature of infant behaviour while using a wahakura, particularly in the bed-sharing situation. Duration of use is six months
Intervention code [1] 257598 0
Other interventions
Comparator / control treatment
Use of an Infant Bassinet beside parents bed for all infant sleeps in the first 6 months of life.
Control group
Active

Outcomes
Primary outcome [1] 259645 0
Duration of time "head covered" while asleep
Timepoint [1] 259645 0
1 month of age
Primary outcome [2] 259646 0
duration of time in thermal comfort while asleep
Timepoint [2] 259646 0
1 month of age
Primary outcome [3] 259647 0
Number of desaturation events while asleep
Timepoint [3] 259647 0
1 month of age
Secondary outcome [1] 266309 0
Duration of "exclusive" and any Breastfeeding
Timepoint [1] 266309 0
6 months

Eligibility
Key inclusion criteria
Infants born in two Hawkes Bay (NZ) Midwifery services
Likely to remain in the local area for at least 6 months
Minimum age
No limit
Maximum age
1 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) <36 weeks gestation, 2) severe congenital anomaly, 3) previous infant who died with unexplained sudden infant death, 4) NICU admission for >3 days, 5) severe mental health problems (as determined by contact with mental health services), 6) involvement in a methadone maintenance programme, 7) multiple pregnancy, 8) is not fluent in English, 9) is already a participant in another infant sleep research study.

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)
All infants who register antenatally with the two midwifery practices will be invited to participate. Mothers agreeing to participate will be randomised to one of the two groups. Allocation will be concealed and performed following application of inclusion/exclusion criteria by opening a sealed envelope opened in numbered sequence. As parity and SES may significantly affect the primary outcomes, stratified block allocation will be used (deprivation quintile derived from home address <3 vs = 3, parity 1 vs >1) with a block size of 3 used within each strata combination.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random-number generator (provided by either SAS 9.1 or Stata 10) will be used to assign blocks of participants to the two arms.
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
Completed
Date of first participant enrolment
Anticipated
1/03/2011
Actual
8/06/2011
Date of last participant enrolment
Anticipated
Actual
28/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 3035 0
New Zealand
State/province [1] 3035 0
hawkes bay

Funding & Sponsors
Funding source category [1] 258045 0
Government body
Name [1] 258045 0
Health Research Council of NZ
Country [1] 258045 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin
New Zealand
Country
New Zealand
Secondary sponsor category [1] 257234 0
None
Name [1] 257234 0
Address [1] 257234 0
Country [1] 257234 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260044 0
Central Regional Ethics Committee
Ethics committee address [1] 260044 0
PO Box 5013
Wellington
Ethics committee country [1] 260044 0
New Zealand
Date submitted for ethics approval [1] 260044 0
19/11/2010
Approval date [1] 260044 0
12/04/2011
Ethics approval number [1] 260044 0
CEN/10/12/054

Summary
Brief summary
Unsafe sleeping environments lead to 40-60 unexpected infant deaths annually in NZ, disproportionately affecting Maori babies. Bed-sharing with baby when the mother smoked in pregnancy is unsafe, but Maori, like other indigenous peoples, have some affinity to bed-sharing, seeing it as promoting breastfeeding and whanau-infant attachment. Also, smoking rates are high amongst pregnant Maori women.

We will evaluate a “safe sleeping device” originating in the Maori community; a woven flax basket called the wahakura, and compare it to a standard bassinet on a number of levels. We will recruit 240 mainly Maori and low socio-economic mothers and their babies from two participating Hawke’s Bay midwifery services. Recruitment during pregnancy will be followed by randomisation to one of the sleeping environments. The study will require a face to face interview in pregnancy; over-night home recording of the infant’s sleep at 1 month old using infra-red video equipment, skin temperature and Haemoglobin oxygen saturation levels; a next morning interview; and follow up interviews at 3 months (face to face) and 6 months (by phone). Key outcome measures will be time head-covered over-night, thermal environment, hypoxic events and amount of breast feeding.
The results will support evidence-based recommendations for safe sleeping of infants
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31907 0
Prof Barry J Taylor
Address 31907 0
Dept of Women's and Children's Health
DUnedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 31907 0
New Zealand
Phone 31907 0
+64 3 21 616 229
Fax 31907 0
Email 31907 0
barry.taylor@otago.ac.nz
Contact person for public queries
Name 15154 0
Dr Dr David Tipene-Leach
Address 15154 0
Dr David Tipene-Leach, MBChB, MCCM(NZ), FRNZCGP. General Practitioner, Te Taiwhenua o Heretaunga. Senior Research Fellow, University of Otago. (Principal Investigator in Hawke’s Bay),
52 Vigor Brown St
Napier South
Napier 4110
Country 15154 0
New Zealand
Phone 15154 0
+ 64 6 8737244
Fax 15154 0
Email 15154 0
dtipene@xtra.co.nz
Contact person for scientific queries
Name 6082 0
Prof Professor Barry Taylor
Address 6082 0
PO Box 913,
Dunedin
Country 6082 0
New Zealand
Phone 6082 0
+64 3 4747748
Fax 6082 0
+64 3 4747817
Email 6082 0
barry.taylor@otago.ac.nz

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
SourceTitleYear of PublicationDOI
EmbasePhysiological stability in an indigenous sleep device: A randomised controlled trial.2018https://dx.doi.org/10.1136/archdischild-2017-313512
Dimensions AIMethodology and recruitment for a randomised controlled trial to evaluate the safety of wahakurafor infant bedsharing2014https://doi.org/10.1186/1471-2431-14-240
N.B. These documents automatically identified may not have been verified by the study sponsor.