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heat loss prevention trial

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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. Over 800 infants were enrolled in the trial. Preliminary data on the primary outcome was presented at the VON annual meeting in 2011. The trial was presented at the Pediatric Academic Societies annual meeting in May 2012. (Reilly MC, Vohra, S, Dunn M, Ferrelli K, Rac V, Vincer M, Wimmer J, Zayack D, Soll R. The Vermont Oxford Network (VON) Heat Loss Prevention (HeLP) Trial. Pediatric Academic Societies' Annual Meeting, Boston, MA. April 29, 2012. plenary presentation).

The steering committee is currently reviewing the drafted manuscript and hope to send it our VON investigators in early 2013 for their review prior to sending for publication. We are also currently drafting papers analyzing data on the infants born at less than 24 weeks gestation, the use of a waiver or institutional consent in the trial, and the follow up data.

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 resulted 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 were randomized as part of a separate Pilot Study and centers choose if they wish to participate in this group or not. Secondary outcome: The key secondary outcomes are axillary temperature taken on introduction into a warm environment in the NICU. We also recorded 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 were also recorded. Long-term follow-up is critical to our understanding of the implications of any new intervention. As such, we asked parents from hospitals who agreed to participate in the follow-up study for permission to contact them approximately 18-24 months after birth.

Study Design
The randomized controlled trial (RCT) is a two-intervention, parallel design. Preterm infants meeting the eligibility criteria were 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.

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

For more information about this study contact Maureen Reilly

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

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