Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

NCT01403623 | Completed Phase 4 DMC

• 1 other identifier: UAB Neo 003
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (\< 36.5 degrees C) without increasing hyperthermia (\> 37.5 degrees C).

Conditions

Hypothermia, Newborn

Keywords

Hypothermia; Newborn; Resuscitation; Plastic bag

Outcome Measures

Primary Outcomes (1)

• Axillary temperature 36.5-37.5 degrees Celsius

  Temperature taken per axilla for 1 minute

  1-4 hours

Secondary Outcomes (12)

• Blood pressure

  Duration of hospitalization-expected average of 4 weeks

• Blood glucose

  Duration of hospitalization-expected average of 4 weeks

• Seizure

  Duration of hospitalization-expected average of 4 weeks

• Weight gain

  Duration of hospitalization-expected average of 4 weeks

• Respiratory Distress Syndrome (RDS)

  Duration of hospitalization-expected average of 4 weeks

Study Arms (2)

Resuscitation with plastic bag

ACTIVE COMPARATOR

Plastic bag will be used during and after resuscitation to assist with temperature regulation.

Procedure: Resuscitation and post resuscitation care with plastic bag

Standard resuscitation- no plastic bag

SHAM COMPARATOR

Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.

Procedure: Resuscitation- no plastic bag for temperature regulation

Interventions

Resuscitation and post resuscitation care with plastic bag PROCEDURE

Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

Resuscitation with plastic bag

Resuscitation- no plastic bag for temperature regulation PROCEDURE

Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

Standard resuscitation- no plastic bag

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
• Delivery in the hospital.

You may not qualify if:

• Abdominal wall defect or myelomeningocele.
• Major congenital anomaly.
• Blistering skin disorder.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (1)

• Leadford AE, Warren JB, Manasyan A, Chomba E, Salas AA, Schelonka R, Carlo WA. Plastic bags for prevention of hypothermia in preterm and low birth weight infants. Pediatrics. 2013 Jul;132(1):e128-34. doi: 10.1542/peds.2012-2030. Epub 2013 Jun 3.

  PMID: 23733796 DERIVED

MeSH Terms

Conditions

Hypothermia

Interventions

Resuscitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics

Study Officials

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

• Alicia E Leadford, 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: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Instructor, Department of Pediatrics, Division of Neonatology

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 27, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

ZA (1)