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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603837
First Posted: January 29, 2008
Last Update Posted: October 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oklahoma
  Purpose
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.

Condition Intervention
Hypothermia Device: NeoWrap Device: InfaTherm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Neonatal Intensive Care Unit (NICU) Admission Temperature [ Time Frame: At time of admission to the NICU - usually within 10-15 min of birth ]

Enrollment: 36
Study Start Date: May 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   24 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603837


Locations
United States, Oklahoma
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Douglas Dannaway, MD University of Oklahoma
Study Director: Parker L Simon, DO, MPH University of Oklahoma
Study Chair: Marilyn Escobedo, MD University of Oklahoma
  More Information

Responsible Party: Douglas C. Dannaway, Oklahoma University Health Science Center
ClinicalTrials.gov Identifier: NCT00603837     History of Changes
Other Study ID Numbers: 13223
First Submitted: December 19, 2007
First Posted: January 29, 2008
Results First Submitted: July 24, 2009
Results First Posted: September 2, 2009
Last Update Posted: October 16, 2009
Last Verified: October 2009

Keywords provided by University of Oklahoma:
Hypothermia
Prevention
ELGANs(Extremely low gestational age neonates)
Polyethylene Wrap
Sodium Acetate Transport Mattress

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms