Optimizing oxygen levels for premature infants during resuscitation
Official title: Optimization of Saturation Targets And Resuscitation (OptiSTART): Multicenter Randomized Controlled Trial
Run by University of Texas Southwestern Medical Center · NCT05849077 · Data updated 2026-11-12
This study is testing which oxygen level is best for helping premature babies during resuscitation at birth to improve their chances of survival and long-term health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Minutes to 10 Minutes |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | February 26, 2024 |
| Main results expected | April 1, 2028 |
| Study ends | April 1, 2029 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT05849077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are neonates born between 22 to 30 weeks of gestational age.
✕Probably not a fit
Patients with prenatally diagnosed cyanotic congenital heart disease or congenital diaphragmatic hernia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to determine the optimal target oxygen saturation (SpO2) range for preterm infants during resuscitation at birth to improve survival rates and reduce long-term health issues. It will compare two different SpO2 targets, Sat75 and Sat50, to assess their impact on neonatal outcomes. The research addresses a critical gap in knowledge regarding oxygen use in neonatal resuscitation, as current guidelines are based on expert opinion rather than empirical evidence. By refining oxygen saturation targets, the study seeks to balance the risks of hypoxia and oxygen toxicity in vulnerable preterm infants.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and reduced long-term morbidities for premature infants.
How similar studies have gone: Other studies have suggested that current oxygen saturation targets may be suboptimal, indicating that this approach could lead to significant advancements in neonatal care.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Texas Southwestern Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Vishal Kapadia, MD — University of Texas Southwestern Medical Center
- Study coordinator: Vishal Kapadia, MD
- Email: vishal.kapadia@utsouthwestern.edu
- Phone: 2146483903
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.