Optimizing oxygen levels for premature infants during resuscitation
Optimization of Saturation Targets And Resuscitation (OptiSTART): Multicenter Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 0 Minutes to 10 Minutes |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05849077 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates born between 22 to 30 weeks of gestational age.
Not a fit: Patients with prenatally diagnosed cyanotic congenital heart disease or congenital diaphragmatic hernia may not benefit from this study.
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 performed: Other studies have suggested that current oxygen saturation targets may be suboptimal, indicating that this approach could lead to significant advancements in neonatal care.
Eligibility criteria
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 this trial is running
Dallas, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.