Methodology and recruitment for a randomised controlled trial to evaluate the safety of wahakura for infant bedsharing
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  • 作者:David Tipene-Leach ; Sally Baddock ; Sheila Williams ; Raymond Jones…
  • 关键词:Sudden Unexpected Death in Infancy ; Sudden Infant Death Syndrome ; Infant ; Sleep ; Prevention ; Culture ; Protocol ; Indigenous ; Bedsharing ; Co ; sleeping
  • 刊名:BMC Pediatrics
  • 出版年:2014
  • 出版时间:December 2014
  • 年:2014
  • 卷:14
  • 期:1
  • 全文大小:550 KB
  • 参考文献:1. Krous, HF, Beckwith, B, Byard, RW, Rognum, TO, Bajanowski, T, Corey, T, Cutz, E, Hanzlick, R, Keens, TG, Mitchell, EA (2004) Sudden infant death syndrome and unclassified sudden infant deaths: A definitional and diagnostic approach. Pediatrics 114: pp. 234-238 CrossRef
    2. Moon, RY, Darnall, RA, Goodstein, MH, Hauck, FR, Willinger, M, Shapiro-Mendoza, CK, Couto, J (2011) SIDS and other sleep-related infant deaths: Expansion of recommendations for a safe infant sleeping environment. Pediatrics 128: pp. e1341-e1367 CrossRef
    Fifth Report to the Minister of Health: Reporting mortality 2002-008. Child and Youth Mortality Review Committee, Wellington, New Zealand
    3. Hauck, FR, Tanabe, KO, Moon, RY (2011) Racial and ethnic disparities in infant mortality. Semin Perinatol 35: pp. 209-220 CrossRef
    4. Collins, SA, Surmala, P, Osborne, G, Greenberg, C, Bathory, LW, Edmunds-Potvin, S, Arbour, L (2012) Causes and risk factors for infant mortality in Nunavut, Canada 1999-011. BMC Pediatr 12: pp. 190 CrossRef
    5. Freemantle, CJ, Read, AW, de Klerk, NH, McAullay, D, Anderson, IP, Stanley, FJ (2006) Patterns, trends, and increasing disparities in mortality for Aboriginal and non-Aboriginal infants born in Western Australia, 1980-001: population database study. Lancet 367: pp. 1758-1766 CrossRef
    6. Mitchell, EA, Brunt, JM, Everard, C (1994) Reduction in mortality from sudden infant death syndrome in New Zealand: 1986-2. Arch Dis Child 70: pp. 291-294 CrossRef
    7. Blair, P, Sidebotham, P, Berry, P, Evans, M, Fleming, P (2006) Major epidemiological changes in sudden infant death syndrome: a 20-year population-based study in the UK. Lancet 367: pp. 314-319 CrossRef
    8. Pickett, KE, Luo, Y, Lauderdale, DS (2005) Widening social inequalities in risk for sudden infant death syndrome. Am J Public Health 95: pp. 1976-1981 CrossRef
    9. Hunt, CE, Hauck, FR (2006) Sudden infant death syndrome. Can Med Assoc J 174: pp. 1861-1869 CrossRef
    10. Mitchell, EA, Milerad, J (2006) Smoking and the sudden infant death syndrome. Rev Environ Health 21: pp. 81-103 CrossRef
    11. Blair, PS, Fleming, PJ, Smith, IJ, Platt, MW, Young, J, Nadin, P, Berry, PJ, Golding, J, Mitchell, E (1999) Babies sleeping with parents: case–control study of factors influencing the risk of the sudden infant death syndromeCommentary: Cot death—the story so far. BMJ 319: pp. 1457-1462 CrossRef
    12. Kahn, A, Blum, D (1982) Phenothiazines and Sudden Infant Death Syndrome. Pediatrics 70: pp. 75-78
    13. Blair, P, Sidebotham, P, Evason-Coombe, C, Edmonds, M, Heckstall-Smith, E, Fleming, P (2009) Hazardous cosleeping environments and risk factors amenable to change: case–control study of SIDS in south west England. BMJ 339: pp. 3666
    14. Carpenter, RG, Irgens, LM, Blair, PS, England, PD, Fleming, P, Huber, J, Jorch, G, Schreuder, P (2004) Sudden unexplained infant death in 20 regions in Europe: case control study. Lancet 363: pp. 185-191 CrossRef
    15. Carroll-Pankhurst, C, Mortimer, EA (2001) Sudden infant death syndrome, bedsharing, parental weight, and age at death. Pediatrics 107: pp. 530-536 CrossRef
    16. Baddock, S, Galland, B, Bolton, D, Williams, S, Taylor, B (2012) Hypoxic and hypercapnic events in young infants during bed-sharing. Pediatrics 130: pp. 237
文摘
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/Design 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. Discussion 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. Trials registration Australian New Zealand Clinical Trials Registry: ACTRN12610000993099 Registered 16th November 2010
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