Comparing higher versus lower oxygen targets for very preterm infants with BPD-related pulmonary hypertension
Official title: Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
Run by University of Alabama at Birmingham · NCT06373289 · Data updated 2026-11-12
This trial will see if keeping very preterm infants with bronchopulmonary dysplasia and pulmonary hypertension at a slightly higher oxygen saturation (95–98%) versus a lower saturation (92–95%) helps them do better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Month to 5 Months |
| Sex | All |
| Enrollment | 39 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Status | Recruiting |
| Started | September 22, 2026 |
| Main results expected | July 6, 2029 |
| Study ends | December 1, 2029 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT06373289 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants born at 22+0 to 31+6 weeks' gestation who have echocardiographic evidence of pulmonary hypertension, are receiving supplemental oxygen, and have mature retinas.
✕Probably not a fit
Infants without BPD-associated pulmonary hypertension, those not on supplemental oxygen, or those with major congenital anomalies are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Preterm infants born between 22 and 31+6 weeks who have bronchopulmonary dysplasia with echocardiographic pulmonary hypertension and are receiving supplemental oxygen are enrolled and randomized. Infants are assigned in a 1:1 crossover design to one week of one SpO2 target (92–95%) and one week of the other target (95–98%), with a one-week washout between exposures. Bedside teams use preset algorithms and Nellcor pulse oximetry sensors to maintain the assigned SpO2 ranges and receive oxygen saturation histograms to monitor performance. The trial compares short-term oxygenation management and related clinical outcomes between the two target ranges.
Why it matters
Potential benefit: If successful, choosing the better oxygen target could reduce hypoxic or hyperoxic complications and possibly improve short-term survival and clinical stability in these high-risk infants.
How similar studies have gone: Prior large neonatal oxygen-target trials have demonstrated important effects of oxygen ranges on outcomes in preterm infants, but applying targeted higher versus lower SpO2 specifically for BPD-associated pulmonary hypertension is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Major congenital anomalies
Where it's running
-
The University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
Yale New Haven Hospital
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Samuel Gentle — Yale University
- Study coordinator: Samuel Gentle, MD
- Email: samjgentle@gmail.com
- Phone: 205-541-2247
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.