NCT00603837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 2, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

1.5 years

First QC Date

December 19, 2007

Results QC Date

July 24, 2009

Last Update Submit

October 12, 2009

Conditions

Hypothermia

Keywords

HypothermiaPreventionELGANs(Extremely low gestational age neonates)Polyethylene WrapSodium Acetate Transport Mattress

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Blanket

EXPERIMENTAL

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

Wrap

EXPERIMENTAL

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

Device: NeoWrap

Interventions

NeoWrapDEVICE

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

Wrap
InfaThermDEVICE

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

Blanket

Eligibility Criteria

Age24 Weeks - 28 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Technical difficulties with the polyethylene wrap were the main limitations (variation of use, heat loss during pulse oximeter adjustment).

Results Point of Contact

Title
Doug Dannaway, MD
Organization
University of Oklahoma Health Sciences Center
douglas-dannaway@ouhsc.edu
405-271-5215

Study Officials

  • Douglas Dannaway, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

  • Parker L Simon, DO, MPH

    University of Oklahoma

    STUDY DIRECTOR

  • Marilyn Escobedo, MD

    University of Oklahoma

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2007

First Posted

January 29, 2008

Study Start

May 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

October 16, 2009

Results First Posted

September 2, 2009

Record last verified: 2009-10

Locations

US(1)