NCT05849077 Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
| NCT ID | NCT05849077 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Premature Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2024-02-26 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: -Neonates with OB gestational age 22-30 weeks Exclusion Criteria: * 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
Contact & Investigator
Vishal Kapadia, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT05849077 clinical trial?
This trial is open to participants of all sexes, aged 0 Minutes or older, up to 10 Minutes, studying Premature Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05849077 currently recruiting?
Yes, NCT05849077 is actively recruiting participants. Contact the research team at vishal.kapadia@utsouthwestern.edu for enrollment information.
Where is the NCT05849077 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT05849077 clinical trial?
NCT05849077 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Vishal Kapadia, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 700 participants.