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Study News
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. Pilot studies have shown that wrapping infants born at less than 28 weeks gestation in polyethylene occlusive wrap immediately after birth improves admission temperature: Based on this evidence NRP has recently considered the use of wrapping infants born at less than 28 weeks gestation.

The HeLP trial, an international randomized control trial, was designed to investigate the effect of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation on mortality. Enrollment began in December 2004 and finished in the spring of 2010. We are currently analyzing the data on the more than 800 infants enrolled in the trial. We hope to present preliminary data at the VON annual meeting in December 2010 and present all data at the Pediatric Academy Societies meeting in May 2011. The HeLP trial steering committee would like to thank all the dedicated VON centers who participated in this study.

For more information about this study contact Maureen Reilly

Study Purpose
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. This ancillary study is in planning stages.

Study Design
The randomized controlled trial (RCT) is a two-intervention, parallel design with a 24 month accrual period. 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. The less than 24 week stratum is being run as a Pilot Study and centers may choose if they wish to participate in this group or not.

Study Sponsors
This study has received funding from the Canadian Institute of Health Research (CIHR).

Principal Investigators
Sunita Vohra, MD,Stollery Children's Hospital, Edmonton, Alberta, Canada
Maureen Reilly, RRT, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Steering Committee
Michael Dunn, MD, FRCPC, Sunnybrook Health Sciences Centre, Professor, University of Toronto
Roger F. Soll, MD, Clinical Trials Director, Vermont Oxford Network; Professor of Pediatrics, University of Vermont
Alex Kiss, PhD, Manager Department of Research Design and Biostatistics Scientist, Clinical Epidemiology Sunnybrook Health Sciences Centre
Michael Vincer, MD, IWK Grace Health Centre
John Wimmer, MD, Associate Professor of Pediatrics, University School of Medicine
Denise Zayack, RN, BA, Director, Neonatal Intensive Care Services; Operations Co-Director, Perinatal & Gynaecology Program, Sunnybrook Health Sciences Centre