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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603837
• Other study ID #: 13223
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: October 12, 2009
• Start date: May 2007
• Est. completion date: November 2008

Study information

• Verified date: October 2009
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Weeks to 28 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

Device:
• NeoWrap
This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.
• InfaTherm
A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.

Locations

Country	Name	City	State
United States	Oklahoma University Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Intensive Care Unit (NICU) Admission Temperature		At time of admission to the NICU - usually within 10-15 min of birth	Yes