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Oxygen Saturation Targeting for Preterm Infants with Pulmonary Hypertension

This study is looking at how different oxygen levels affect preterm infants (babies born early) who have bronchopulmonary dysplasia (a chronic lung disease) and pulmonary hypertension (high blood pressure in the lungs). About half of extremely preterm infants develop bronchopulmonary dysplasia, and some also develop pulmonary hypertension, which can be very serious. Doctors want to find the best oxygen levels to help these babies. This trial will compare two different oxygen saturation targets: a lower target (92-95%) and a higher target (95-98%) using Nellcor pulse oximetry sensors. We are looking for 39 infants, aged 1 to 5 months, who were born between 22 and 31 weeks of pregnancy and have been diagnosed with pulmonary hypertension by an echocardiogram (a heart ultrasound). The main goal is to see how long episodes of low oxygen (intermittent hypoxemia) last for each group, measured until 3 weeks after joining or until discharge.

Study design
This is an interventional study with 39 participants. It uses a crossover design where infants will switch between the two oxygen target groups.
What's involved
Participants will be exposed to one oxygen target for one week, then switch to the other target for another week, with a one-week break in between.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured from the date of randomization until 3 weeks have passed or the date of discharge, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06373289

Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

Recruiting
NAAges 1–5InterventionalTreatment
University of Alabama at Birmingham
~39 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:higher oxygen saturation target using Nellcor pulse oximetry sensorslower oxygen saturation target using Nellcor pulse oximetry sensors

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intermittent hypoxemia event duration
Measured over From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

Conditions

Bronchopulmonary Dysplasia
Pulmonary Hypertension

Explore related trials

Bronchopulmonary DysplasiaPulmonary Hypertension

Where it's being run

2 sites across 2 states
Alabama1
Connecticut1

Study leadership

  • Samuel Gentle · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Samuel Gentle, MD
[email protected]
205-541-2247
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Between 22w 0/7d and 31w 6/7d gestation at birth
Diagnosed with echocardiographic pulmonary hypertension (1) \>20% flow of blood across the PDA from the pulmonary to arterial circulation, (2) end-systolic flattening of the interventricular septum (eccentricity index \>1.3), or (3) right ventricular pressure estimates ≥ 35 mm Hg
Receiving supplemental oxygen
Have mature retinas

Exclusion

Major congenital anomalies

What this trial measures

  • Intermittent hypoxemia event durationFrom date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

    The average duration of time (in seconds) an infant's oxygen saturation decrease below 80%.