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Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room

NCT00607464 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2016-04-25

No results posted yet for this study

Summary

Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)?

Conditions

  • Hypothermia in Premature Infants

Interventions

DEVICE

Polyethylene occlusive skin wrap

Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Vermont Oxford Network

    collaborator NETWORK

  • University of Alberta

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Maureen C Reilly, RRT · Sunnybrook Health Sciences Centre

  • Sunita Vohra, MD FRCPC MSc · University of Alberta/Stollery Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2010-03-31
Completion
2012-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00607464 on ClinicalTrials.gov