Clinical trial Recruiting at 1 site Interventional Ages 0 Minutes to 10 Minutes

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 typeInterventional
Ages0 Minutes to 10 Minutes
SexAll
Enrollment700 (estimated)
SponsorUniversity of Texas Southwestern Medical Center
Academic / other
Locations1 site (Dallas, Texas)
StatusRecruiting
StartedFebruary 26, 2024
Main results expectedApril 1, 2028
Study endsApril 1, 2029
Registry record updatedNovember 6, 2026
Trial IDNCT05849077 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.