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

Neonatal Adaptation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250079
• Other study ID #: polyethylene29
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2014
• Last updated: September 23, 2014
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Universidad Nacional de Colombia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Ethics CommitteeColombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 29 Weeks to 42 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Adaptation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Hospital de la Victoria	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Temperature	The Student's t test and U of Mann Whitney were used to compare temperature	10 minutes	No
Primary	Humidity	The Student's t test and U of Mann Whitney were used to compare relative humidity.	10 minutes	No
Secondary	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	Yes