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Oxygen Saturation Levels for Premature Infants (OptiSTART Trial)
N/A
Recruiting
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
Neonates with OB gestational age 22-30 weeks
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented diagnosis or date of death from any cause or date of discharge, whichever came first, assessed up to 36 months
Awards & highlights
OptiSTART Trial Summary
This trial will see if higher oxygen levels during resuscitation of preterm babies increases survival without long-term complications. 700 babies will be randomly assigned to two different oxygen levels and the study aims to determine which level is optimal.
Who is the study for?
The OptiSTART trial is for premature infants born between 22-30 weeks of gestation. It's not suitable for those with certain heart diseases, if oxygen saturation can't be measured within 3 minutes after birth, or if parents do not wish resuscitation.Check my eligibility
What is being tested?
This study tests two different oxygen saturation targets during the resuscitation of preterm babies: Sat75 (higher target) and Sat50 (current standard). The goal is to see which leads to better survival rates without lung disease or neurodevelopmental issues by age two.See study design
What are the potential side effects?
Potential side effects are related to the levels of oxygen received. Too much oxygen might lead to conditions like retinopathy (eye damage) or affect lung development, while too little could result in inadequate tissue oxygenation.
OptiSTART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born between 22 and 30 weeks of pregnancy.
OptiSTART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of first documented diagnosis or date of death from any cause or date of discharge, whichever came first, assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented diagnosis or date of death from any cause or date of discharge, whichever came first, assessed up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival without BPD
Secondary outcome measures
Bronchopulmonary Dysplasia
Delivery Room Intubation
Length of hospitalization
+8 moreOptiSTART Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sat75Experimental Treatment1 Intervention
FiO2 will be titrated every 30 seconds by 0.2-0.3 to achieve target SpO2 that approximates the 75th percentile SpO2 observed in healthy term newborns. Percentiles are roughly based on Dawson reference curves of healthy term infants after birth.
Group II: Sat50Active Control1 Intervention
FiO2 will be titrated every 30 seconds by 0.1-0.2 to achieve NRP recommended target SpO2 which approximates the 50th percentile SpO2 observed in healthy term newborns. Percentiles are roughly based on Dawson reference curves of healthy term infants after birth.
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,057 Previous Clinical Trials
1,054,415 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,598 Previous Clinical Trials
2,286,062 Total Patients Enrolled
5 Trials studying Bronchopulmonary Dysplasia
1,335 Patients Enrolled for Bronchopulmonary Dysplasia
University of OklahomaOTHER
455 Previous Clinical Trials
94,935 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
210 Patients Enrolled for Bronchopulmonary Dysplasia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born between 22 and 30 weeks of pregnancy.My unborn baby has been diagnosed with a heart condition that decreases oxygen in the blood.If the oxygen levels in the baby's blood cannot be measured within 3 minutes of putting the pulse oximeter sensor on the baby.My parents have decided against resuscitation measures for me.My unborn baby has been diagnosed with a diaphragm hernia.
Research Study Groups:
This trial has the following groups:- Group 1: Sat75
- Group 2: Sat50
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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