Wrapping Versus Infant Mattress for Prevention of hYpothermia Study - Full Text View

Sponsored by:	University of Oklahoma
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00603837

Purpose

Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and VLBW babies who are placed on thermal warming blankets.

Condition	Intervention
Hypothermia	Device: NeoWrap Device: InfaTherm

MedlinePlus related topics: Dietary Sodium Hypothermia

Drug Information available for: Sodium acetate Acetic acid, sodium salt

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Wrapping Versus Infant Mattress for Prevention of hYpothermia Study

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

NICU Admission Temperature [ Time Frame: At time of admission to the NICU - usually within 10-15 min of birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cost comparison between polyethylene wrap and sodium acetate warming mattresses [ Time Frame: after enrollment of all patients ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Blanket: Experimental This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.	Device: InfaTherm A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.
Wrap: Experimental This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.	Device: NeoWrap This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.

Eligibility

Ages Eligible for Study:	24 Weeks to 28 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603837

Contacts

Contact: Douglas Dannaway, MD	(405) 271-5215	Douglas-Dannaway@ouhsc.edu
Contact: Parker L Simon, DO, MPH	(405) 271-5215	Parker-Simon@ouhsc.edu

Locations

United States, Oklahoma
Oklahoma University Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

University of Oklahoma

Investigators

Principal Investigator:	Douglas Dannaway, MD	University of Oklahoma
Study Director:	Parker L Simon, DO, MPH	University of Oklahoma
Study Chair:	Marilyn Escobedo, MD	University of Oklahoma

More Information

Responsible Party:	Oklahoma University Health Science Center ( Douglas C. Dannaway )
Study ID Numbers:	13223
Study First Received:	December 19, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00603837
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

Hypothermia
Prevention
ELGANs

Extremely low gestational age neonates
Polyethylene Wrap
Sodium Acetate Transport Mattress

Study placed in the following topic categories:

Signs and Symptoms
Hypothermia

Additional relevant MeSH terms:

Body Temperature Changes

ClinicalTrials.gov processed this record on January 14, 2009