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LOWER oxygen saturation target group for Lung Disease (BPD STAR Trial)

N/A

Waitlist Available

Led By Sara DeMauro, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current age 34 0/7 to 43 6/7 weeks postmenstrual age

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 40 weeks pma and 6 months corrected age

Awards & highlights

BPD STAR Trial Summary

This trial will evaluate whether infants with established BPD fare better with higher or lower oxygen saturation levels.

Eligible Conditions

Lung Disease
Bronchopulmonary Dysplasia

BPD STAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You must be between 34 to 43 weeks since your last menstrual period.

BPD STAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 40 weeks pma and 6 months corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 40 weeks pma and 6 months corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 40 weeks pma and 6 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intermittent hypoxemia (IH)

Secondary outcome measures

Development

Duration of hypoxia

Feeding

+8 more

BPD STAR Trial Design

2Treatment groups

Active Control

Group I: LOWER oxygen saturation target groupActive Control1 Intervention

Oxygen saturation target range 90--94%. The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm.

Group II: HIGHER oxygen saturation target groupActive Control1 Intervention

Oxygen saturation target range greater than or equal to 96%.The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

707 Previous Clinical Trials

8,581,241 Total Patients Enrolled

Thrasher Research FundOTHER

132 Previous Clinical Trials

94,324 Total Patients Enrolled

Sara DeMauro, MDPrincipal InvestigatorThe Childrens Hospital of Pennsylvania

1 Previous Clinical Trials

483 Total Patients Enrolled

Frequently Asked Questions

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

Is the research team actively seeking participants for this investigation?

"Per the clinicaltrials.gov website, this particular medical trial is no longer recruiting patients as of July 15th 2022 - its last update date. This study was first advertised on June 1st 2018 and despite it being inactive now, there are currently 584 other trials actively seeking participants."

Answered by AI

Does this research welcome individuals aged 25 years or older?

"According to the criteria listed, individuals aged 34 to 44 weeks are eligible for this study. There are 247 trials open for those under 18 and 352 studies available for applicants over 65 years of age."

Answered by AI

What type of individuals is ideal for recruitment in this experiment?

"For this medical research, 50 premature infants aged between 34 weeks and 44 weeks suffering from bronchopulmonary dysplasia can enroll. Eligible candidates must have been born before the 30th week of gestation and never discharged home from hospital care. Additionally, they need to meet a moderate or severe severity designation based on NIH's consensus definition."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BPD Saturation TARgeting

Sara B. DeMauro, MD MSCE 2018. "BPD Saturation TARgeting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03385330.