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OpenTrials
Completed

NCT Number: NCT00603837

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

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.

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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

24 week–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NeoWrap

Device

This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.

InfaTherm

Device

A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.

Primary outcomes

  1. Neonatal Intensive Care Unit (NICU) Admission Temperature

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 29, 2008
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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