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临床试验/NCT02250079
NCT02250079已完成3 期

Features and Differences Between Neonates Undergoing Body Bag With Polyethylene and Conventional Drying During Neonatal Adaptation in Maternal and Child Headquarters Hospital and the Victoria Hospital Engativá, Bogotá, 2013

Universidad Nacional de Colombia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Temperature

研究概览

简要总结

INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in the basic technology for neonatal adaptation may not be available. Polyethylene bags may be an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the differences between babies undergoing body bag with polyethylene or conventional drying during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá, Colombia, 2013.

MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag body and / or radiant heat lamp was removed. Environment temperature and humidity, temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of the outcome. The study was approved by the hospital ethics committee of victory.

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
29 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Inborn neonates with both a gestational age >29 weeks

排除标准

  • •Abdominal wall defect, myelomeningocele, major congenital anomaly, or blistering skin disorder

研究组 & 干预措施

Polyethilene body bag group

Experimental

The intervention group infants were provided the same care as control infants, but were dressed with the polyethylene body bag immediately after birth. The bag had an upper opening for the head and a seal at the bottom. The intervention group infants remained in the plastic bag for the first 10 minutes after birth. The same process was done in surgery room in case of cesarean. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process were done in surgery room in case of cesarean

干预措施: polyethylene plastic bag (Device)

Conventional group

Active Comparator

): Infants randomized to the control group received standard hospital care newborn. This included immediate drying, skin-to-skin contact, early and exclusive breast feeding, postponed bathing, bundling, and radiant warmer. While waiting for criteria cord clamping, the environment humidity and temperature and segment and rectal temperature of the newborn were measure. It was repeated at 1-5- 10-60 and 120 minutes. After clamping, the newborn were positioned in a radiant warmer, and completed the drying process. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process was done in surgery room in case of cesarean.

干预措施: Conventional treatment (Device)

结局指标

主要结局

Temperature

时间窗: 10 minutes

The Student's t test and U of Mann Whitney were used to compare temperature

Humidity

时间窗: 10 minutes

The Student's t test and U of Mann Whitney were used to compare relative humidity.

次要结局

  • Both, Hypothermia or Hyperthermia(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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