Methodology and recruitment for a randomised controlled trial to evaluate the safety of wahakurafor infant bedsharingReportar como inadecuado

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BMC Pediatrics

, 14:240

Health behavior, health promotion and society


BackgroundSudden Unexpected Death in Infancy SUDI has persistent high rates in deprived indigenous communities and much of this mortality is attributable to unsafe sleep environments. Whilst health promotion worldwide has concentrated on avoidance of bedsharing, the indigenous Māori community in New Zealand has reproduced a traditional flax bassinet wahakura designed to be used in ways that include bedsharing. To date there has been no assessment of the safety of this traditional sleeping device.

Methods-DesignThis two arm randomised controlled trial is being conducted with 200 mother-baby dyads recruited from Māori communities in areas of high deprivation in the Hawkes Bay, New Zealand. They are randomised to wahakura or bassinet use and investigation includes questionnaires at baseline pregnancy, when baby is 1, 3, and 6 months, and an overnight video sleep study at 1 month with monitoring of baby temperature and oxygen saturation, and measurement of baby urinary cotinine and maternal salivary oxytocin. Outcome measures are amount of time head covered, amount of time in thermal comfort zone, number of hypoxic events, amount of time in the assigned sleep device, amount of time breastfeeding, number of parental non-feed related touching infant events, amount of time in the prone sleep position, the number of behavioural arousals and the amount of time infant is awake overnight. Survey data will compare breastfeeding patterns at 1, 3, and 6 months as well as data on maternal mind-mindedness, maternal wellbeing, attachment to baby, and maternal sleep patterns.

DiscussionIndigenous communities require creative SUDI interventions that fit within their prevailing world view. This trial, and its assessment of the safety of a wahakura relative to a standard bassinet, is an important contribution to the range of SUDI prevention research being undertaken worldwide.

Trials registrationAustralian New Zealand Clinical Trials Registry: ACTRN12610000993099 Registered 16 November 2010

KeywordsSudden Unexpected Death in Infancy Sudden Infant Death Syndrome Infant Sleep Prevention Culture Protocol Indigenous Bedsharing Co-sleeping Electronic supplementary materialThe online version of this article doi:10.1186-1471-2431-14-240 contains supplementary material, which is available to authorized users.

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Autor: David Tipene-Leach - Sally Baddock - Sheila Williams - Raymond Jones - Angeline Tangiora - Sally Abel - Barry Taylor


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