Primary Investigator
Purpose: Oxygen is the most commonly used drug during preterm resuscitation, but its use has been linked to mortality and several morbidities such as bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), and retinopathy of prematurity (ROP).Preterm infants at birth are more vulnerable to oxygen toxicity caused by exposure to high concentrations of oxygen during resuscitation, but are also equally vulnerable to the adverse effects of suboptimal oxygen use in the delivery room. This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: What is the optimal target oxygen saturation (SpO2) range that increases survival without long-term morbidities?
Study design: A prospective multicenter randomized controlled trial of Sat75 versus Sat50 will be conducted. As per the current NRP guidelines, resuscitation will be initiated with 0.3 FiO2 in both intervention and control groups. The study intervention is the Sat75 where FiO2 will be titrated every 30 seconds by 0.1-0.2 to achieve target SpO2 that approximates the 75th percentile SpO2 observed in healthy term newborns. The control group is the Sat50 where FiO2 will be titrated by 0.2-0.3 every 30 seconds to achieve the NRP recommended target SpO2 which approximates the 50th percentile SpO2 observed in healthy term newborns. In the rare event, where chest compressions are needed during delivery room resuscitation, the FiO2 will be increased to 1.0 as per current NRP guidelines. Once the heart rate (HR) is stabilized, the FiO2 will be reduced to meet the target SpO2. Apart from the randomly assigned target SpO2, resuscitation will follow current NRP guidelines. Assignment to the Sat75 or Sat50 group will use a 1:1 allocation ratio and stratification by GA: 23 0/7 to 27 6/7 weeks and 28 0/7 to 30 6/7 weeks. Demographics, perinatal variables, resuscitation characteristics and neonatal morbidity-mortality data and data of Neurodevelopmental follow-up at around 2 years of age will be electronically recorded using the web-based data entry system developed by the Data Coordinating Center.
You may be eligible for this study if you meet the following criteria:
Inclusion Criteria:
Exclusion Criteria:
This study investigates the optimal oxygen saturation levels needed during resuscitation for preterm infants. Preterm infants are babies born too early and they can have problems with their lungs and other organs. The study looks at two different ways to give oxygen to these infants to see which one helps them survive better without long-term health problems.
In this study, babies will be placed into one of two study arms. One arm will aim for a higher oxygen level, similar to healthy newborns, while the other arm will aim for a moderate oxygen level. The oxygen given will be adjusted every 30 seconds to reach the target levels. This will help doctors understand the best way to give oxygen to preterm babies.
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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