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临床试验/NCT02897388
NCT02897388已完成不适用

A Quality Improvement Initiative to Increase Breast Milk Use in a Chinese Neonatal Intensive Care Unit (NICU): a Pilot Study

Children's Hospital of Fudan University0 个研究点目标入组 325 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
325
主要终点
prevalence of breast milk feeding

研究概览

简要总结

To assess the prevalence of breast milk feeding in a NICU in China, to implement a quality improvement program to increase breast milk feeding, and to evaluate its impact.

详细描述

The benefits of breast milk are well recognized for providing health benefits in early infancy and extending into adulthood, and breast milk feeding is promoted by numerous professional organizations. However, for various reasons, in neonatal intensive care unit in China, most infants are separated from their parents and are fed infant formula exclusively. To address this problem, the investigators propose to carry out a pilot study to assess the prevalence of breast milk feeding in a NICU of a tertiary teaching hospital in China, and then to introduce an intervention program to increase the prevalence of breast milk feeding and to evaluate the impact of this program.

The intervention would include building a nutrition team in the NICU, training of a lactation coordinator and nursing staff by a team from Mount Sinai Hospital, providing parents with education on breast milk feeding, providing access to breast pumps through a lend/lease program and providing a breast pumping room for parents. The investigators will collect data on breast milk feeding, including prevalence and reasons for not breast milk feeding during both the pre-intervention and intervention period. The investigators will also assess the enrolled infants' weight gain from admission to discharge, incidence of nosocomial infection and mortality, and average length of stay in the NICU, to assess the efficacy of the breast milk feeding intervention.

This trial has the potential to dramatically change feeding of infants in Chinese NICUs from exclusive infant formula to breast milk, with potential impacts on nosocomial infection, growth, development and hospital length of stay.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
— 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • all very low birth weight(birthweight ≤ 1500g)infants admitted to the NICU of Children's Hospital of Fudan University
  • informed consent is given

排除标准

  • Presence of breast milk feeding contraindications
  • Severe illness with contraindications for feeding

结局指标

主要结局

prevalence of breast milk feeding

时间窗: up to 18 months

to compare the breast milk feeding incidence between pre-intervention and intervention period

次要结局

  • Nosocomial infection incidence(up to 18 months)
  • Necrotizing enterocolitis(NEC) incidence(up to 18 months)
  • overall mortality rate(up to 18 months)
  • time to full feeding(up to 18 months)

研究者

申办方类型
Other
责任方
Sponsor

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