Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)

Recruiting now · Not applicable

Conditions studied: Premature Infants, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Neurodevelopmental Outcomes

In brief

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? Oxygen (O2) is routinely used for the stabilization of preterm infants in the delivery room (DR), but its use is linked with mortality and several morbidities including bronchopulmonary dysplasia (BPD). To balance the need to give sufficient O2 to correct hypoxia and avoid excess O2, the neonatal resuscitation program (NRP) recommends initiating preterm resuscitation with low (≤ 30%) inspired O2 concentration (FiO2) and subsequent titration to achieve a specified target SpO2 range. These SpO2 targets are based on approximated 50th percentile SpO2 (Sat50) observed in healthy term infants. However, the optimal SpO2 targets remain undefined in the preterm infants. Recent data suggest that the current SpO2 targets (Sat50) may be too low. The investigators plan to conduct a multicenter RCT of Sat75 versus Sat50 powered for survival without BPD. The investigators will randomize 700 infants, 23 0/7- 30 6/7 weeks' GA, to 75th percentile SpO2 goals (Sat75, Intervention) or 50th percentile SpO2 goals (Sat50, control). Except for the SpO2 targets, all resuscitations will follow NRP guidelines including an initial FiO2 of 0.3. In Aim 1, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without lung disease (BPD). In addition, the investigators will compare the rates of other major morbidities such as IVH. In Aim 2, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without neurodevelopmental impairment at 2 years of age. In Aim 3, the investigators will determine whether targeting Sat75 compared to Sat50 decreases oxidative stress.

Key facts

Study ID: NCT05849077
Run by: University of Texas Southwestern Medical Center
People needed: 700
Starts: 2024-02-26
Expected to finish: 2029-04-01
Last updated by the study team: 2025-08-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Neonates with OB gestational age 22-30 weeks

You may not qualify if…

Prenatally diagnosed cyanotic congenital heart disease
Prenatally diagnosed congenital diaphragmatic hernia
Parents request no resuscitation
If preductal saturations can not be measured by 3 minutes after pulse oximeter sensor is applied to the newborn

Where it is running

University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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