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OX25 for Stress Oxidative (STARTPreterm Trial)

N/A
Waitlist Available
Led By Vishal Kapadia, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 hours after birth and at 24 hours
Awards & highlights

STARTPreterm Trial Summary

This trial is testing whether using different oxygen levels when resuscitating premature babies in the delivery room can reduce oxidative stress. There are three different oxygen levels being tested, and the objective is to compare the oxidative stress markers between the groups.

STARTPreterm Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 hours after birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 hours after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Oxidative Balance Ratio from Baseline
Secondary outcome measures
Bronchopulmonary dysplasia (BPD)
Grade III/IV Intraventricular hemorrhage
Incidence of bradycardia during resuscitation
+8 more

STARTPreterm Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: OX25Experimental Treatment1 Intervention
Resuscitation will be initiated at 30% O2. Titration of oxygen during neonatal resuscitation: Intervention is target goal saturations which will be the 10th to 25th percentile saturations observed in healthy term newborns.
Group II: OX75Active Control1 Intervention
Resuscitation will be initiated at 30% O2. Titration of oxygen during neonatal resuscitation: Intervention is target goal saturations which will be the 75th percentile saturations observed in healthy term newborns.
Group III: OX50Active Control1 Intervention
Resuscitation will be initiated with 30% O2 and target goal saturations will be the approximated median SpO2 observed in healthy term newborns as per current NRP guidelines

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,724 Total Patients Enrolled
1 Trials studying Stress Oxidative
88 Patients Enrolled for Stress Oxidative
American Academy of PediatricsOTHER
40 Previous Clinical Trials
1,016,393 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,962 Previous Clinical Trials
2,674,654 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Saturation Targets and Resuscitation in Preterm Trial
Vishal Kapadia 2017. "Saturation Targets and Resuscitation in Preterm Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03115463.
~10 spots leftby Apr 2025
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