UPMC Newborn Medicine Program Takes Part in OptiStart Clinical Trial
February 28, 2024
The UPMC Newborn Medicine Program and UPMC Magee-Womens Hospital Neonatal Intensive Care Unit (NICU) are proud to announce their participation in the Optimization of Saturation Targets and Resuscitation Trial (OptiSTART), a multicenter, randomized controlled trial designed by principal investigator Dr. Vishal Kapadia of UT Southwestern Medical Center.
Alice Randall, MD, MPH, assistant professor of Pediatrics in the Division of Newborn Medicine, will be the site principal investigator at the UPMC Magee location. Dr. Randall is the associate medical director of the NICU at UPMC Magee as well as director of NICU Triage. Dr. Randall is joined by division study co-investigators Toby Yanowitz, MD, MS, and John Ibrahim, MD.
The OptiSTART study is anticipated to begin recruitment at UPMC Magee in mid-2024.
Study Overview and Aims
The goal of the OptiSTART study is to identify optimal target blood oxygen levels for preterm infants at birth to reduce unnecessary oxidative stress and its detrimental effects in this vulnerable population.
A pilot study led Dr. Kapadia evaluated 75 preterm babies born at Parkland Memorial Hospital and compared outcomes of those receiving resuscitation using standard blood oxygen targets with those resuscitated using higher blood oxygen targets. The infants in the higher blood oxygen group were quicker to achieve normal breathing, reached the goal heart rate of above 100 beats per minute sooner, had better brain oxygenation, suffered from less oxidative stress, and were more likely to survive without chronic lung disease.
The new study led by Dr. Kapadia aims to verify these findings in a much larger sample of 800 preterm infants born at medical centers across the country.
Study Protocol Reference
For additional details and to read the complete study protocol use the following link: Optimization of Saturation Targets and Resuscitation Trial (OptiSTART). ClinicalTrials.gov ID: NCT05849077.
