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Completed

NCT Number: NCT02250079

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

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.

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Key information

Conditions

Neonatal Adaptation

Age range

29 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de la Victoria

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inborn neonates with both a gestational age >29 weeks

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Temperature

    Time frame: 10 minutes

    The Student's t test and U of Mann Whitney were used to compare temperature

  2. Humidity

    Time frame: 10 minutes

    The Student's t test and U of Mann Whitney were used to compare relative humidity.

Secondary outcomes

  1. Both, Hypothermia or Hyperthermia

    Time frame: 10 minutes

    Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of hypothermia, hyperthermia and APGAR.

Other outcomes

  1. Baseline Charasteristics

    Time frame: 10 minutes

    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.

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Colombia

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2014
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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