Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV

NCT01604447 | Completed Phase 4 DMC

• 1 other identifier: UAB Neo 009
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

Conditions

Hypothermia

Keywords

Hypothermia; Newborn; Incubator; Plastic bag; Normothermia

Outcome Measures

Primary Outcomes (1)

• Axillary temperature 36.5-37.5 degrees Celsius

  Temperature taken per axilla for one minute

  1-72 hours

Secondary Outcomes (16)

• Blood pressure

  Up to 4 weeks

• Blood glucose

  Up to 4 weeks

• Seizure

  Up to 4 weeks

• Weight gain

  Up to 4 weeks

• Respiratory Distress Syndrome (RDS)

  Up to 4 weeks

Study Arms (2)

Incubator removal-torso bag

ACTIVE COMPARATOR

Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator

Procedure: Hypothermia prevention with plastic bag

Incubator removal-no plastic bag

PLACEBO COMPARATOR

Standard bundling practices when removing the infant from the incubator. No plastic bag used.

Procedure: Hypothermia prevention without plastic bag

Interventions

Hypothermia prevention with plastic bag PROCEDURE

Upon removal from the incubator, infant will be placed into a plastic bag to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

Incubator removal-torso bag

Hypothermia prevention without plastic bag PROCEDURE

Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

Incubator removal-no plastic bag

Eligibility Criteria

• Age: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant admitted to the NICU
• Current weight less than 2,000g
• Being removed from incubator

You may not qualify if:

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Children's of Alabama: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

ZA (1)