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临床试验/NCT04282655
NCT04282655已完成不适用

The Effect of a Continuous Milk Warming System on Feeding Tolerance and Growth Rates in Very Low Birth Weight Infants

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年9月2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
44
试验地点
2
主要终点
Weight Gain

研究概览

简要总结

This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard method does not keep the breast milk at a consistent temperature during the feeding. A continuous milk warmer maintains the breast milk at body temperature throughout the feeding. It is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.

详细描述

The aim of this randomized prospective quasi-experimental study is to determine if providing body temperature breast milk feedings to very low birth weight infants through use of continuous milk warmer improves feeding tolerance and weight gain compared to a standard milk warming technique.

Warming breast milk in a hot water bath just prior to feeding prior to feeding in the neonatal intensive care unit is a common practice. However, little evidence is available to support a standard warming method. This method allows inconsistent temperatures at time of feeding and progressive cooling of the milk during the feeding. No published study used a continuous warming device that delivered milk at a consistent physiological temperature throughout the feeding. The continuous warmer externally heats milk in the tubing just posterior to the feeding tube to provide body temperature milk to the infant.

A convenience sample from the Children's Hospital at OU Medical Center of 50 very low birth weight infants will be randomly assigned to either the experimental or control group for ten days. The experimental group will receive warmed feedings through the duration of the feeding through the use of the Guardian Warmer™, a continuous milk warming device. A control group will receive breast milk feedings warmed using the standard milk warming methods. Feeding tolerance and weight gain over the ten-day period will be used to evaluate the effectiveness of continuous milk warming.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age 28-32 weeks on full enteral feeding of breast milk

排除标准

  • Mechanical ventilation
  • Positive End Expiratory Pressure (PEEP)
  • Total parenteral nutrition, or any congenital anomalies
  • Severe to moderate respiratory disease
  • Previous medical or surgical necrotizing enterocolitis.

结局指标

主要结局

Weight Gain

时间窗: At study completion, 10 days.

Comparison of two groups for weight gain over time in grams

Feeding Intolerance

时间窗: At study completion, 10 days

Comparison of feeding tolerance between groups using a residual algorithm

次要结局

  • Head Circumference(At study completion, 10 days)
  • Body Length(At Study completion, 10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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