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

NCT00603837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-10-16

Study results available
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Summary

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.

Conditions

  • Hypothermia

Interventions

DEVICE

NeoWrap

This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.

DEVICE

InfaTherm

A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Douglas Dannaway, MD · University of Oklahoma

  • Parker L Simon, DO, MPH · University of Oklahoma

  • Marilyn Escobedo, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603837 on ClinicalTrials.gov