NCT02250079

Polyethylene Body Bags as an Alternative to Radiant Heat Lamp During the Neonatal Adaptation in Infants Older Than 29 Weeks

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Universidad Nacional de Colombia · Academic / Other
• Sex: All
• Age: 29 Weeks – 42 Weeks
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Neonatal Adaptation

Interventions

Type	Name	Description
DEVICE	polyethylene plastic bag	Inborn neonates with both a gestational age \>29 weeks were randomized 1:1 to either a standard thermoregulation protocol or placement of a Poliethylene body bag since birth to 10 minutes after birth.
DEVICE	Conventional treatment	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2014-09-26
• Last updated: 2014-09-26

Locations

1 site across 1 country: Colombia