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NCT05849077 · ClinicalTrials.gov registry record · NA
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
A NA study of Bronchopulmonary Dysplasia and Intraventricular Hemorrhage, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 700
- Enrollment target
- 1
- Study location
NCT05849077 is a NA study of Bronchopulmonary Dysplasia and Intraventricular Hemorrhage that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 700 participants, above the 212-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (230% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05849077, a NA study of Bronchopulmonary Dysplasia and Intraventricular Hemorrhage, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 700 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Sat75
- OTHER Sat50
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2024-02-26 |
| Est. Completion | 2029-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05849077
The ClinicalTrials.gov registry entry for NCT05849077 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 212-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (230% higher). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which Sat75 is the first listed.
NCT05849077 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05849077 about?
NCT05849077 is a clinical study titled "Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)". 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 ...
What is the current status of trial NCT05849077?
This trial is currently recruiting. It is a NA study. The enrollment target is 700 participants. The study started on 2024-02-26. Estimated completion is 2029-04-01.
What conditions does trial NCT05849077 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Premature Infants, Neurodevelopmental Outcomes.
What interventions are being tested in trial NCT05849077?
The interventions under investigation include: Sat75 (OTHER), Sat50 (OTHER).
Who is sponsoring clinical trial NCT05849077?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05849077 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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