Neonatal Trials Group
The Neonatal Trials Group (NTG) conducts randomized controlled trials on the aspects of neonatal care in babies. Originally part of the Clinical Trials Methodology Group, NTG was established as a separate entity in 2006 when it joined the Thrombosis and Hemostasis Program and subsequently became part of TAARI with the move to the new research facility at the David Braley Research Institute. NTG’s academic home is in the department of Clinical Epidemiology and Biostatistics in the Faculty of Health Sciences.
Typically, NTG studies assess the efficacy and safety of common, but insufficiently evaluated, neonatal therapies in very small babies born prematurely who spend their first few months in a neonatal intensive care unit (NICU). The group strives to determine the relative merits of competing care strategies both in terms of medical outcome in the short-term (to initial discharge from the NICU) but, more importantly, in longer term mental and physical outcome. By the standards of the pediatric research community, the trials conducted by NTG are large, with sample sizes of up to 2000 babies. All NTG trials are multi-centered in that eligible babies are recruited from participating Canadian and international NICUs.
The members of the NTG include a biostatistician (Robin Roberts), pediatricians/neonatal specialists (Drs. Barbara Schmidt and Haresh Kirpalani), research manager (Lorrie Costantini), research assistant (Wendy Yacura), research nurse/consultant/specialist (Judy D’ilario, Joanne Dix), IT/database consultant (Harvey Nelson), and various undergraduate and graduate students.
The majority of our trials have been funded primarily by the Canadian Institutes of Health Research (CIHR). Although a Canadian-based funding agency, CIHR has recognized that these neonatal trials require an international scope partly to facilitate timely recruitment, but also to foster international collaboration. We are currently conducting two international, randomized controlled trials each involving more than 1000 babies recruited from up to 40 clinical sites world-wide. In addition, we are continuing extended follow-up at age 11-12 years of participants in our earlier trial of caffeine in 2000 babies. We recently completed and published the results of assessment at 5 years of age for this trial. NTG is also involved in analyzing data from previously conducted follow-up trials. Our group has successfully completed three large randomized trials; the results of all three trials were reported in high-impact journals and have led to a variety of subsidiary publications.
For more information about the NTG and our clinical trials, follow the link below.