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

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Device: InfaTherm; Device: NeoWrap

• Registration Number: NCT00603837
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-29
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-07-24
• Results First Submitted QC: 2009-07-24
• Results First Posted: 2009-09-02
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-12
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blanket	InfaTherm	This arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery.
Wrap	NeoWrap	This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.

Primary Outcome Measures

Name	Time	Method
Neonatal Intensive Care Unit (NICU) Admission Temperature	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.

Trial Locations

Locations (1)

Oklahoma University Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States