CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
LOWER oxygen saturation target group +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03385330N/ACompleted
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The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial

Children's Hospital of Philadelphia·interventional·Posted Dec 28, 2017·Updated Apr 30, 2024

In Brief

A clinical study evaluating LOWER oxygen saturation target group and HIGHER oxygen saturation target group for Bronchopulmonary Dysplasia and 2 related conditions. Completed, enrolled 50 participants across 3 sites.

Detailed Summary

Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD. Participants will be randomly placed in either a higher oxygen saturation group or a lower oxygen saturation target group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease
CountriesUnited States
CollaboratorsThrasher Research Fund

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 28, 2017
Enrollment StartJun 1, 2018
Primary CompletionFeb 1, 2023
Study CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 8.5 years ago

Interventions

LOWER oxygen saturation target groupother

We will randomize infants with moderate or severe BPD to lower SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.

HIGHER oxygen saturation target groupother

We will randomize infants with moderate or severe BPD to higher SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.