NCT01604421

Brief Summary

The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

5.7 years

First QC Date

May 21, 2012

Last Update Submit

February 18, 2019

Conditions

Hypothermia

Keywords

HypothermiaLow birth weightNewbornPlastic bagThermoregulation

Outcome Measures

Primary Outcomes (1)

  • Axillary temperature < 36.5 degrees Celsius

    Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and \<32.0 as severe hypothermia.

    Discharge or 24 hours after birth

Secondary Outcomes (8)

  • Seizure

    Up to 4 weeks

  • Respiratory Distress Syndrome (RDS)

    Up to 4 weeks

  • Pneumothorax

    Up to 4 weeks

  • Sepsis

    Up to 4 weeks

  • Necrotizing enterocolitis or intestinal perforation

    Up to 4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Thermoregulation-standard care

SHAM COMPARATOR

Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first.

Procedure: Thermoregulation-standard care

Thermoregulation-with plastic bag

ACTIVE COMPARATOR

Thermoregulation with plastic bag covering torso and lower extremities from one hour after birth until discharge or 24 hours after birth to assist with thermoregulation. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.

Procedure: Thermoregulation with plastic bag

Interventions

Thermoregulation-standard carePROCEDURE

Standard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.

Thermoregulation-standard care
Thermoregulation with plastic bagPROCEDURE

One hour after birth, the infant will be placed into a plastic bag up to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first.

Thermoregulation-with plastic bag

Eligibility Criteria

Age1 Hour - 120 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g
  • Delivery in the hospital

You may not qualify if:

  • Infant admitted to the NICU
  • Birth weight less than 1400 gms
  • Abdominal wall defect or myelomeningocele
  • Major congenital anomalies
  • Blistering skin disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Body Temperature Regulation

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body TemperaturePhysiological PhenomenaHomeostasisAdaptation, PhysiologicalAdaptation, BiologicalBiological Phenomena

Study Officials

  • Waldemar A Carlo, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Edwin M. Dixon Professor of Pediatrics

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

February 1, 2013

Primary Completion

October 1, 2018

Study Completion

October 1, 2019

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations

ZA(1)