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临床试验/ACTRN12612001024831
ACTRN12612001024831已完成未知

Does providing first time mothers (who are planning to breastfeed) with telephone peer support from volunteer mothers (compared with usual care) increase the proportion feeding their infant any breast milk at six months postpartum

Mother and Child Health Research, La Trobe University0 个研究点目标入组 1,157 人开始时间: 2012年9月24日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
1,157

研究概览

简要总结

Background: Breastfeeding rates are suboptimal internationally, and many infants are not receiving any breast milk at all by six months of age. Few interventions increase breastfeeding duration, particularly where there is relatively high initiation. The effect of proactive peer (mother-to-mother) support has been found to increase breastfeeding in some contexts but not others, but if it is shown to be effective would be a potentially sustainable model in many settings. We aimed to determine whether proactive telephone-based peer support during the postnatal period increases the proportion of infants being breastfed at six months of age. Methods: RUBY (Ringing Up about Breastfeeding earlY)was a multicentre, two-armun-blinded randomised controlled trial conducted in three hospitals in Victoria, Australia. First-time mothers intending to breastfeed were recruited after birth and prior to hospital discharge, and randomly assigned (1:1) to usual care or usual care plus proactive telephone-based breastfeeding support from a trained peer volunteer for up to six months postpartum. A computerised random number program generated block sizes of four or six distributed randomly, with stratification by site. Research midwives were masked to block size, but masking of allocation was not possible.The primary outcome was the proportion of infants receiving any breast milk at six months of age. Analyses were by intention to treat; data were collected and analysed masked to group. The trial is registered with ACTRN, number 12612001024831. Findings: Women were recruited between Feb 14, 2013 and Dec 15, 2015 and randomly assigned to peer support (n=574) or usual care (n=578). Five were not in the primary analysis [5 post-randomisation exclusions]. Infants of women allocated to telephone-based peer supportwere more likely than those allocated to usual care to be receiving breast milk at six months of age (intervention 75%, usual care 69%; Adj. RR 1·10; 95% CI 1·02, 1·18). There were no adverse events. Interpretation: Providing first time mothers with telephone-based support from a peer with at least six months personal breastfeeding experience is an effective intervention for increasing breastfeeding maintenance in settings with high breastfeeding initiation

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
16 Years 至 o limit(—)
性别
Female

入选标准

  • English speaking
  • Mother having her first live baby
  • Breastfeeding or intending to breastfeed
  • Giving birth in a public hospital

排除标准

  • Very ill women.
  • Women who do not have the capacity to consent, including women who are highly dependent on medical care, and those with an intellectual or mental impairment to the extent that they could not provide informed consent.Mother of babies born prematurely or babies remaining in hospital after the mother's discharge after birth. Women with antenatal membership of the Australian Breastfeeding Association

研究者

发起方
Mother and Child Health Research, La Trobe University

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