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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

OptiSTART 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,035 Total Patients Enrolled

University of Alabama at BirminghamOTHER

1,590 Previous Clinical Trials

2,280,962 Total Patients Enrolled

5 Trials studying Bronchopulmonary Dysplasia

1,335 Patients Enrolled for Bronchopulmonary Dysplasia

University of OklahomaOTHER

455 Previous Clinical Trials

95,223 Total Patients Enrolled

1 Trials studying Bronchopulmonary Dysplasia

210 Patients Enrolled for Bronchopulmonary Dysplasia

Media Library

Sat75 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05849077 — N/A

Bronchopulmonary Dysplasia Research Study Groups: Sat75, Sat50

Bronchopulmonary Dysplasia Clinical Trial 2023: Sat75 Highlights & Side Effects. Trial Name: NCT05849077 — N/A

Sat75 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05849077 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial accept participants aged 80 or above?

"According to the conditions of participation, applicants must be between 0 minutes and 10 years old. There are 143 studies specifically for minors and 313 trials focusing on seniors over 65."

Answered by AI

What demographic is eligible to participate in this research?

"This trial requires participants to have bronchopulmonary dysplasia and be between 0 Minutes and 10 Minutes old. 700 individuals will comprise the cohort for this research."

Answered by AI

Are there still opportunities to participate in this investigation?

"The clinical trial listed on clinicialtrials.gov is not currently taking participants, as evidenced by the last modification date of May 4th 2023. Despite this, there are over 450 other studies actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)

Vishal Kapadia 2024. "Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05849077.