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

Primary Purpose

Hypothermia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NeoWrap

InfaTherm

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring Hypothermia, Prevention, ELGANs(Extremely low gestational age neonates), Polyethylene Wrap, Sodium Acetate Transport Mattress

Eligibility Criteria

24 Weeks - 28 Weeks (Child)All SexesAccepts 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.

Sites / Locations

Oklahoma University Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Blanket

Wrap

Arm Description

This arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery.

This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.

Outcomes

Primary Outcome Measures

Neonatal Intensive Care Unit (NICU) Admission Temperature

Axillary temperature of the infant upon arrival to the neonatal intensive care unit.

Secondary Outcome Measures

Full Information

NCT ID

NCT00603837

First Posted

December 19, 2007

Last Updated

October 12, 2009

Sponsor

University of Oklahoma

1. Study Identification

Unique Protocol Identification Number

NCT00603837

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oklahoma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypothermia

Keywords

Hypothermia, Prevention, ELGANs(Extremely low gestational age neonates), Polyethylene Wrap, Sodium Acetate Transport Mattress

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blanket

Arm Type

Experimental

Arm Description

This arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery.

Arm Title

Wrap

Arm Type

Experimental

Arm Description

This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.

Intervention Type

Device

Intervention Name(s)

NeoWrap

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

InfaTherm

Intervention Description

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

Primary Outcome Measure Information:

Title

Neonatal Intensive Care Unit (NICU) Admission Temperature

Description

Axillary temperature of the infant upon arrival to the neonatal intensive care unit.

Time Frame

At time of admission to the NICU - usually within 10-15 min of birth

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Weeks

Maximum Age & Unit of Time

28 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas Dannaway, MD

Organizational Affiliation

University of Oklahoma

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Parker L Simon, DO, MPH

Organizational Affiliation

University of Oklahoma

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Marilyn Escobedo, MD

Organizational Affiliation

University of Oklahoma

Official's Role

Study Chair

Facility Information:

Facility Name

Oklahoma University Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

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

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