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临床试验/NCT04492579
NCT04492579已完成不适用

Neonates Supplemented With Gentle-UHT Donor Human Milk in the First Week of Life

LactaLogics, Inc2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Weight gain

研究概览

简要总结

This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 4 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age >36 weeks
  • Exclusively fed human milk
  • Age <96 hours (4 days)

排除标准

  • Previous admittance to the neonatal intensive care unit
  • Supplementation of any formula

结局指标

主要结局

Weight gain

时间窗: 8-9 days of life

Average weights compared to WHO data

次要结局

  • Exclusive human milk diet(8-9 days of life)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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