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

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. Identifier: NCT00603837
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : September 2, 2009
Last Update Posted : October 16, 2009
Information provided by:
University of Oklahoma

Brief 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.

Condition or disease Intervention/treatment
Hypothermia Device: NeoWrap Device: InfaTherm

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Study Start Date : May 2007
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

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.

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00603837

United States, Oklahoma
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
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

Responsible Party: Douglas C. Dannaway, Oklahoma University Health Science Center Identifier: NCT00603837     History of Changes
Other Study ID Numbers: 13223
First Posted: January 29, 2008    Key Record Dates
Results First Posted: September 2, 2009
Last Update Posted: October 16, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms