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BPD Saturation TARgeting

NCT03385330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-30

Study results available
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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.

Conditions

Interventions

OTHER

LOWER oxygen saturation target group

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.

OTHER

HIGHER oxygen saturation target group

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.

Sponsors & Collaborators

Principal Investigators

  • Sara DeMauro, MD · The Childrens Hospital of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2023-02-01
Completion
2023-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03385330 on ClinicalTrials.gov