Optimization of Saturation Targets And Resuscitation (OptiSTART): Multicenter Randomized Controlled Trial

What this Trial Is About

Researchers are studying the best oxygen saturation (SpO2) targets to improve survival without long-term lung and brain problems in preterm infants born between 23 and 30 weeks gestational age. Oxygen is commonly used to help these infants at birth, but too much or too little oxygen can cause serious health issues like bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), and retinopathy of prematurity (ROP). This trial compares two different SpO2 targets to find the optimal range that balances oxygen benefits and risks during resuscitation. The study randomly assigns about 700 preterm infants to one of two groups: the first group (Sat75) targets oxygen saturations around the 75th percentile of healthy term newborns, while the second group (Sat50) targets the 50th percentile as currently recommended. Both groups start resuscitation with 30% oxygen (FiO2) and adjust oxygen levels every 30 seconds to reach their assigned SpO2 target. Resuscitation follows neonatal resuscitation program (NRP) guidelines, and if chest compressions are needed, oxygen is increased to 100% temporarily. After initial care, further medical decisions are made by the clinical team. Participants will be closely monitored during delivery room resuscitation and throughout their hospital stay. Researchers will record oxygen levels, heart rate, breathing efforts, and major health outcomes like survival without BPD at 36 weeks postmenstrual age. They will also assess other complications such as IVH and neurodevelopmental impairment up to two years of age. Oxidative stress levels shortly after birth will be measured to understand oxygen-related injury. Data will be collected electronically and analyzed to determine which oxygen target improves survival and reduces complications.

Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)