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

• 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

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