NCT01604460

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 V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

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

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
9 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

May 21, 2012

Last Update Submit

February 8, 2013

Conditions

HypothermiaNewborn

Keywords

HypothermiaNewbornPlastic bagResuscitation

Outcome Measures

Primary Outcomes (1)

  • Axillary temperature < 36.5 degrees Celsius

    Temperature taken per axilla at one hour after birth. Temperatures 36.0-16.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and \< 32.0 will be classified as severe hypothermia.

    1-72 hours

Secondary Outcomes (4)

  • Sepsis

    Up to 72 hours

  • Death

    Up to 72 hours

  • Hyperthermia

    Up to 72 hours

  • Room Temperature

    1-72 hours

Study Arms (2)

Resuscitation-no plastic bag

SHAM COMPARATOR

Resuscitation per standard of care without a plastic bag

Procedure: Resuscitation-no plastic bag

Resuscitation-torso bag

ACTIVE COMPARATOR

Use of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth

Procedure: Resuscitation with torso plastic bag

Interventions

Resuscitation with torso plastic bagPROCEDURE

Infant will be placed within 10 minutes of his birth into a plastic bag 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. After his/her head is dried, the infant will receive a cloth cap. Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth.

Resuscitation-torso bag
Resuscitation-no plastic bagPROCEDURE

Infant will be immediately dried and resuscitated in the delivery room per standard of care. The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery.

Resuscitation-no plastic bag

Eligibility Criteria

Age1 Minute - 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Estimated gestational age 37 weeks and greater
  • Birth weight greater than 2,500gms
  • Delivery in the hospital

You may not qualify if:

  • Infant admitted to the NICU
  • Birth weight less than 2,500gms
  • 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

Related Publications (1)

  • Belsches TC, Tilly AE, Miller TR, Kambeyanda RH, Leadford A, Manasyan A, Chomba E, Ramani M, Ambalavanan N, Carlo WA. Randomized trial of plastic bags to prevent term neonatal hypothermia in a resource-poor setting. Pediatrics. 2013 Sep;132(3):e656-61. doi: 10.1542/peds.2013-0172. Epub 2013 Aug 26.

    PMID: 23979082DERIVED

MeSH Terms

Conditions

Hypothermia

Interventions

Resuscitation

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Emergency TreatmentTherapeutics

Study Officials

  • Waldemar A Carlo, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
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

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

November 1, 2012

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

ZA(1)