title: Methodology and recruitment for a randomised controlled trial to evaluate the safety of wahakura for infant bedsharing.
abstract: BACKGROUND
  Sudden 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
  This 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.
  
  
  CONCLUSIONS
  Indigenous 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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12610000993099 Registered 16th November 2010.
authors.forename: David
authors.initials: D
authors.lastname: Tipene-Leach
authors.forename: Sally
authors.initials: S
authors.lastname: Baddock
authors.forename: Sheila
authors.initials: S
authors.lastname: Williams
authors.forename: Raymond
authors.initials: R
authors.lastname: Jones
authors.forename: Angeline
authors.initials: A
authors.lastname: Tangiora
authors.forename: Sally
authors.initials: S
authors.lastname: Abel
authors.affiliation: Women's and Children's Health, Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin, New Zealand. barry.taylor@otago.ac.nz.
authors.forename: Barry
authors.initials: B
authors.lastname: Taylor
mesh_terms: D001513:Beds; D001831:Body Temperature; D001942:Breast Feeding; D003367:Cotinine / Q000652:urine; D003469:Culture; D005006:Ethnicity; D006801:Humans; D007223:Infant; D015370:Infant Equipment; D007231:Infant, Newborn; D018670:Monitoring, Ambulatory; D009034:Mother-Child Relations; D009035:Mothers; D009520:New Zealand; D010100:Oxygen / Q000097:blood; D010121:Oxytocin / Q000032:analysis; D016684:Prone Position; D012463:Saliva / Q000737:chemistry; D012890:Sleep; D013398:Sudden Infant Death / Q000517:prevention & control*; D014851:Wakefulness
chemical_list: D010121:Oxytocin; D003367:Cotinine; D010100:Oxygen