None listed
Conditions
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
Interventions
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 recom
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
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 1 Days
Healthy volunteers
Yes
Inclusion criteria
Infants born in two Hawkes Bay (NZ) Midwifery services Likely to remain in the local area for at least 6 months
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.
Outcome results
None listed