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

NCT02250079 | Completed Phase 3 DMC

• 1 other identifier: polyethylene29
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Adaptation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Both, Hypothermia or Hyperthermia

  10 minutes

Other Outcomes (1)

• Baseline Charasteristics

  10 minutes

Study Arms (2)

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

Device: polyethylene plastic bag

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.

Device: Conventional treatment

Interventions

polyethylene plastic bag DEVICE

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.

Polyethilene body bag group

Conventional treatment DEVICE

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.

Conventional group

Eligibility Criteria

• Age: 29 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Hospital de la Victoria

Bogotá, Colombia

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 26, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

CO (1)