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

NCT ID: NCT00603837

Last Updated: 2009-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-11-30

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.

Conditions

Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Blanket

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

Group Type: EXPERIMENTAL

InfaTherm

Intervention Type: DEVICE

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

Wrap

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

Group Type: EXPERIMENTAL

NeoWrap

Intervention Type: DEVICE

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

Interventions

NeoWrap

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

Intervention Type: DEVICE

InfaTherm

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 28 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Oklahoma University Health Science Center

Principal Investigators

Douglas Dannaway, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Parker L Simon, DO, MPH

Role: STUDY_DIRECTOR

University of Oklahoma

Marilyn Escobedo, MD

Role: STUDY_CHAIR

University of Oklahoma

Locations

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

13223

Identifier Type: -

Identifier Source: org_study_id