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

NCT ID: NCT00607464

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 804 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2012-10-31

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)?

Detailed Description

Thermoregulation is a major problem for low birth weight infants. The EPICure study showed that 36% of infants born between 24 and 25 weeks gestation had an admission temperature less than 35 degrees Celsius. Hypothermia is associated with increased risk of morbidity and mortality. The HeLP trial hopes to address these issues with the use of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation. Forty-five centers are currently involved in this study. Infant enrollments began in December 2004.

Primary outcome: To determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation results in decreased mortality compared with the conventional method of drying. Because of increased mortality and variable center specific resuscitation practices, infants born at less than 24 weeks gestation will be randomized as part of a separate Pilot Study and centers may choose if they wish to participate in this group or not. Secondary outcome: The key secondary outcome will be axillary temperature taken on introduction into a warm environment in the NICU. We will also record clinically important variables including: acidosis, hypotension, hypoglycaemia, seizures, patent ductus arteriosus, respiratory distress syndrome/chronic lung disease, necrotizing enterocolitis and head ultrasound results. Length of stay and cause of death at discharge will also be recorded. Long-term follow-up is critical to our understanding of the implications of any new intervention. As such, we ask parents from hospitals who agree to participate in the follow-up study for permission to contact them approximately 18 months after birth.

Preterm infants meeting the eligibility criteria will be randomly assigned within three gestational age strata (less than 24 weeks, 24+0 to 25+6 weeks gestation, and 26+0 to 27+6 weeks gestation) to either the occlusive skin wrap group or the standard of care (non-wrap) group.

Conditions

Hypothermia in Premature Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Polyethylene occlusive skin wrap

Intervention Type: DEVICE

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

2

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

occlusive skin wrap

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 28 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Vermont Oxford Network

NETWORK

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Maureen Reilly

RRT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maureen C Reilly, RRT

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Sunita Vohra, MD FRCPC MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta/Stollery Children's Hospital

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25449224 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23770234 (View on PubMed)

Related Links

http://www.vtoxford.org

The Vermont Oxford Network

Other Identifiers

ISRCTN85045728

Identifier Type: -

Identifier Source: secondary_id

MCT-71137

Identifier Type: -

Identifier Source: org_study_id