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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypothermia

Intervention / Treatment
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* Device: NeoWrap
* Device: InfaTherm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 28 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blanket<br>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<br>* A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.<br>|
| Experimental: Wrap<br>This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery. | Device: NeoWrap<br>* This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Intensive Care Unit (NICU) Admission Temperature | Axillary temperature of the infant upon arrival to the neonatal intensive care unit. | At time of admission to the NICU - usually within 10-15 min of birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Prevention, ELGANs(Extremely low gestational age neonates), Polyethylene Wrap, Sodium Acetate Transport Mattress