RecruitingNot ApplicableNCT05849077

Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

700 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 MinutesMax Age: 10 Minutes

Plain Language Summary

Simplified for easier understanding

This trial (OptiSTART) tests what the optimal oxygen saturation target should be during resuscitation of extremely premature newborns — specifically those born between 22 and 30 weeks of gestation. In the delivery room, healthcare teams use supplemental oxygen to support these fragile babies, but too little oxygen can cause brain injury while too much can damage the eyes, lungs, and other organs. Current guidelines suggest specific oxygen saturation ranges in the first minutes of life, but the ideal targets remain uncertain. OptiSTART directly tests whether different saturation targets during resuscitation lead to better or worse short-term outcomes. Eligible participants are extremely premature neonates (22-30 weeks gestational age at birth). Exclusions are narrow: babies with prenatally diagnosed cyanotic congenital heart disease (where low oxygen is intentional), congenital diaphragmatic hernia (where oxygen management differs significantly), families who have requested no resuscitation, or cases where a pulse oximeter reading cannot be reliably obtained within 3 minutes of birth. Participants will be randomized to one of two oxygen saturation targets during their resuscitation in the delivery room, with outcomes including survival, brain injury markers, and need for oxygen support tracked. This research is critically important because prematurity is the leading cause of neonatal death and disability globally, and the first minutes of life — when the baby is transitioning from the womb environment — are among the most consequential. Even modest improvements in resuscitation protocols could translate into thousands of lives saved and serious disabilities prevented each year.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSat75

As per the current NRP guidelines, resuscitation will be initiated with 0.3 FiO2. FiO2 will be titrated every 30 seconds by 0.2-0.3 to achieve target SpO2 that approximates the 75th percentile SpO2 observed in healthy term newborns. Percentiles are roughly based on Dawson reference curves of healthy term infants after birth. Apart from the randomly assigned target SpO2, resuscitation will follow the current NRP guidelines. Following NICU admission, all care decisions, including ventilator management, will be at the discretion of the clinical team.

OTHERSat50

As per the current NRP guidelines, resuscitation will be initiated with 0.3 FiO2. FiO2 will be titrated every 30 seconds by 0.1-0.2 to achieve target SpO2 that approximates the 50th percentile SpO2 observed in healthy term newborns. Percentiles are roughly based on Dawson reference curves of healthy term infants after birth. Apart from the randomly assigned target SpO2, resuscitation will follow the current NRP guidelines. Following NICU admission, all care decisions, including ventilator management, will be at the discretion of the clinical team.


Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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