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

NCT01604434 | Withdrawn DMC

• 1 other identifier: UAB Neo 008
• Study Type: interventional
• Target: N/A
• 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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.

Conditions

Hypothermia

Keywords

Hypothermia; Low birth Weight; Newborn; Incubator; Plastic bag

Outcome Measures

Primary Outcomes (1)

• Axillary temperature 36.5-37.5 degrees Celsius

  Temperature taken per axilla for 1 minute

  1-72 hours

Secondary Outcomes (15)

• 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) Respiratory Distress Syndrome (RDS)

  Up to 4 weeks

Study Arms (2)

Incubator-no plastic bag

SHAM COMPARATOR

Placement into an incubator without a plastic bag

Procedure: Incubator-no plastic bag

Incubator-torso bag

ACTIVE COMPARATOR

Placement into a plastic bag inside incubator

Procedure: Incubator-torso bag

Interventions

Incubator-torso bag PROCEDURE

While being placed into an 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 over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.

Incubator-torso bag

Incubator-no plastic bag PROCEDURE

Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.

Incubator-no plastic bag

Eligibility Criteria

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

You may qualify if:

• Infant admitted to the NICU
• Current weight between 1,000 and 2,500g
• Being placed in an 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 Health System, 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: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edwin M. Dixon Professor of Pediatrics

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

ZA (1)