NCT00607464

Brief 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)?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
804

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

5.5 years

First QC Date

January 22, 2008

Last Update Submit

April 21, 2016

Conditions

Hypothermia in Premature Infants

Keywords

Hypothermia, premature infants, Polyethylene occlusive wrap

Outcome Measures

Primary Outcomes (1)

  • Death to discharge or at six months corrected gestational age

    discharge or six months corrected gestational age

Secondary Outcomes (4)

  • 1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU)

    upon arrival in NICU

  • acidosis, hypotension, hypoglycaemia, seizures

    first 12 hours of life

  • 4. Death and neurosensory disability measured at 18 months corrected gestational age

    18 months corrected gestational age

  • PDA, RDS, CLD, pneumothorax, sepsis, IVH, PVL, NEC, GI perforation, pulmonary hemorrhage, hearing, ROP

    discharge from hospital or 6 months corrected gestational age

Study Arms (2)

1

EXPERIMENTAL

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

Device: Polyethylene occlusive skin wrap

2

NO INTERVENTION

Standard care

Interventions

Polyethylene occlusive skin wrapDEVICE

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

Also known as: occlusive skin wrap
1

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (2)

  • Reilly MC, Vohra S, Rac VE, Dunn M, Ferrelli K, Kiss A, Vincer M, Wimmer J, Zayack D, Soll RF; Vermont Oxford Network Heat Loss Prevention (HeLP) Trial Study Group. Randomized trial of occlusive wrap for heat loss prevention in preterm infants. J Pediatr. 2015 Feb;166(2):262-8.e2. doi: 10.1016/j.jpeds.2014.09.068. Epub 2014 Nov 12.

    PMID: 25449224DERIVED

  • Vohra S, Reilly M, Rac VE, Bhaloo Z, Zayack D, Wimmer J, Vincer M, Ferrelli K, Kiss A, Soll R, Dunn M. Study protocol for multicentre randomized controlled trial of HeLP (Heat Loss Prevention) in the delivery room. Contemp Clin Trials. 2013 Sep;36(1):54-60. doi: 10.1016/j.cct.2013.06.001. Epub 2013 Jun 11.

    PMID: 23770234DERIVED

Related Links

MeSH Terms

Conditions

HypothermiaPremature Birth

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Maureen C Reilly, RRT

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Sunita Vohra, MD FRCPC MSc

    University of Alberta/Stollery Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RRT

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

September 1, 2004

Primary Completion

March 1, 2010

Study Completion

October 1, 2012

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

CA(1)