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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Adaptation
• Intervention / Treatment: Device: polyethylene plastic bag; Device: Conventional treatment

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Bogota, Colombia
    • Hospital de la Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polyethilene body bag group; 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	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.
Active Comparator: Conventional group; ): 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Charasteristics	The baseline characteristics of each group were compared using descriptive statistics. The Student's t test and x2 were used to compare continuous and categorical variables, respectively. Fisher's exact test was used for events with low prevalence.	10 minutes

Collaborators and Investigators

• Sponsor: Universidad Nacional de Colombia

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 8, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Estimate): September 26, 2014
• Last Update Submitted That Met QC Criteria: September 23, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: polyethylene29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No