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Optimizing Oxygen for Premature Infants (OptiSTART)

This study, called OptiSTART, is looking for premature infants born between 22 and 30 weeks of pregnancy to help us understand the best way to give oxygen right after birth. We are comparing two different approaches to oxygen levels (called Sat75 and Sat50) during resuscitation. Doctors currently use oxygen to help premature babies, but too much or too little can cause problems like bronchopulmonary dysplasia (BPD), a lung condition. The goal is to find the oxygen target that helps babies survive without developing BPD. This study is for newborns aged 0 to 10 minutes who do not have certain heart or breathing conditions, or whose parents have not requested no resuscitation. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 700 participants. It compares two different oxygen target levels during resuscitation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure survival without BPD at 36 weeks Postmenstrual Age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05849077

Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)

Recruiting
NAAges 0–10InterventionalTreatment
University of Texas Southwestern Medical Center
~700 participants
Updated 2025-08-05 on ClinicalTrials.gov
What's tested:Sat75Sat50

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survival without BPD
Measured over 36 weeks Postmenstrual Age

Conditions

Premature Infants
Bronchopulmonary Dysplasia
Intraventricular Hemorrhage
Neurodevelopmental Outcomes

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Premature infant

NCT05849077

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Vishal Kapadia, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Vishal Kapadia, MD
[email protected]
2146483903
Email the study team

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Eligibility criteria

Inclusion

Neonates with OB gestational age 22-30 weeks

Exclusion

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

What this trial measures

  • Survival without BPD36 weeks Postmenstrual Age

    The primary outcome for this trial is survival without BPD at 36 weeks' PMA. Both components, death and BPD, will also be reported separately. Neonatal mortality during the NICU stay, the postnatal day at the time of mortality and the primary cause of mortality will be recorded. BPD will be defined as the need for any form of positive airway pressure support or supplemental O2 at 36 weeks' PMA.BPD will be graded as mild, moderate and severe as per the NICHD consensus definition. All eligible infants will undergo room air challenge at 36 weeks' PMA for the physiologic definition of BPD.