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临床试验/ACTRN12617000805370
ACTRN12617000805370已完成未知

Enabling Safe and Close Care in Postnatal Environments: a pilot trial of portable neonatal sleep spaces to support optimal breastfeeding, close care and safe sleep

Sunshine Coast University Hospital0 个研究点目标入组 94 人开始时间: 2017年6月1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
94

研究概览

简要总结

This pilot study aimed to determine the acceptability and feasibility of two novel infant sleep spaces for newborns devised to promote closeness and consistency with safe sleeping recommendations within the Sunshine Coast Hospital and Health Service (SCHHS) maternity unit. Impact upon breastfeeding outcomes and maternal-infant attachment were monitored to inform the development of a larger trial. The study utilised a concurrent mixed methods design with a pilot observational descriptive and randomised controlled design. The trial was conducted in three phases: 1) pilot of the study protocol with mothers and babies (Phase 1 and 2), and 2) evaluation of staff perceptions relating to impact of the safe sleep enablers on provision of care, and awareness of safe sleeping recommendations (Phase 3). The trial is in the preliminary analysis phase, however results to date show that the study cots give mothers more opportunities and choices to care for their baby than the standard newborn cots. Bed sharing is common both in hospital and in the community. Midwives do provide essential SUDI prevention education; however some do not emphasise the importance of childhood immunisations and the risks associated with sleeping an infant with an adult on the sofa. Breastfeeding rates were well above the national average by 4 months of age. No adverse events were reported during the course of this trial.

研究设计

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

入排标准

年龄范围
15 Years 至 o limit(—)
性别
Female

入选标准

  • Maternal participants
  • -greater than or equal to 36 weeks of gestation at time of consent
  • -Attending the SCUH for antenatal care
  • -Intending to be admitted to the postnatal ward at the SCUH after the birth
  • -English speaking
  • -Intending to breastfeed
  • -Singleton pregnancy
  • -BMI less than 40
  • -greater than or equal to 15 years of age
  • -Ability to read and understand English

排除标准

  • -less than 36 weeks of gestation at time of consent
  • -Maternal condition which significantly interferes with breastfeeding
  • -Intending to feed infant with artificial formula
  • -Maternal BMI greater than or equal to 40
  • -less than 15 years of age
  • -Multiple pregnancy
  • -Newborn admitted to SCN or NICU immediately after birth
  • -Neonate requiring phototherapy with or without CPAP
  • -Inability to read and understand English

研究者

发起方
Sunshine Coast University Hospital

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