Research Ethics and Policy Series (REPS) | Haresh Kirpalani, MD, MSc and Chris Feudtner, MD, PhD, MPH

The sustained aeration of infant lung (SAIL) RCT: Balancing ethics and the need for evidence

Haresh Kirpalani, MD, MSc
Emeritus Professor CE of Pediatrics, Perelman School of Medicine

Commentary by Chris Feudtner, MD, PhD, MPH
Attending Physician and Research Director, PACT & ICS, CHOP
Professor of Medical Ethics and Health Policy, PSOM

Register in advance via Zoom:
https://zoom.us/j/91215612903

Description: Dr. Haresh Kirpalani is Emeritus Professor on the pediatrics faculty at CHOP and McMaster University in Canada. He has been pursuing randomized trial evaluation of common therapies in newborn and pediatric ICU medicine, including a trial completed out of the University of Pennsylvania as the lead site—the Sustained Aeration of the Infant Lung (SAIL) RCT (Kirpalani H, JAMA 2019; 321:1165-1175). This trial addressed emergent management of the preterm infant who fails to transition to an extrauterine environment at birth. As a delivery room trial of an emergent therapy it faced special challenges of parent information and informed consent. Internationally the climate for the practice of deferred consent for research involving in sick preterm newborns in the delivery room varies a great deal. In the SAIL trial, the data safety and monitoring board (DSMB) noted an unexpected complication of early death within 48 hours of delivery in the experimental arm. The trial was therefore stopped early (426 instead of 600 as planned). Dr. Kirpalani will discuss the SAIL trial, its results, and the discussions that followed. Dr. Chris Feudtner will then comment on the ethical importance of clinical trials of common therapies and the ethics of deferred consent in clinical research.

See below for speaker bios:
Haresh Kirpalani, MD, MSc
Chris Feudtner, MD, PhD, MPH

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