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

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status

Completed

Conditions

Hypothermia

Treatments

Device: InfaTherm
Device: NeoWrap

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

24 to 28 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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