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

Phase 3

Completed

• Conditions: Neonatal Adaptation
• Interventions: Device: Conventional treatment; Device: polyethylene plastic bag

• Registration Number: NCT02250079
• Lead Sponsor: Universidad Nacional de Colombia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-23
• Last Update Submitted: 2014-09-23
• Study First Posted: 2014-09-26
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Inborn neonates with both a gestational age >29 weeks

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional group	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.
Polyethilene body bag group	polyethylene plastic bag	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

Primary Outcome Measures

Name	Time	Method
Temperature	10 minutes	The Student's t test and U of Mann Whitney were used to compare temperature
Humidity	10 minutes	The Student's t test and U of Mann Whitney were used to compare relative humidity.

Secondary Outcome Measures

Name	Time	Method
Both, Hypothermia or Hyperthermia	10 minutes	Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of hypothermia, hyperthermia and APGAR.

Trial Locations

Locations (1)

Hospital de la Victoria; 🇨🇴 Bogota, Colombia