Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.

October 12, 2009 updated by: University of Oklahoma

Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap

Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming blankets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants in this study will be selected from the inborn population at University Hospital. Eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and <1250g.

Exclusion Criteria:

  • Congenital anomalies with open lesions such as meningomyelocele, or omphaloceles
  • Blistering skin conditions

  • Resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current NRP recommendations):

    • Where gestation, birth weight, and/or congenital anomalies are associated with almost certain early death, and unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. Exceptions may be made based on parental desires.

      • Newborns with confirmed gestation age of less than 24 weeks or birth weight less than 400 grams
      • Anencephaly
      • Confirmed Trisomy 13 or Trisomy 18 syndrome
      • Meconium staining of amniotic fluid
      • Birth assessment of gestational age > 28 weeks or >1250 grams
      • Maternal temp >38 degrees C around the time of delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Blanket
This arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery.
Device: InfaTherm
A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.
EXPERIMENTAL: Wrap
This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
Device: NeoWrap
This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Intensive Care Unit (NICU) Admission Temperature
Time Frame: At time of admission to the NICU - usually within 10-15 min of birth
Axillary temperature of the infant upon arrival to the neonatal intensive care unit.
At time of admission to the NICU - usually within 10-15 min of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Study Director: Parker L Simon, DO, MPH, University of Oklahoma
  • Study Chair: Marilyn Escobedo, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

January 28, 2008

First Posted (ESTIMATE)

January 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2009

Last Update Submitted That Met QC Criteria

October 12, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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