Comparing higher versus lower oxygen targets for very preterm infants with BPD-related pulmonary hypertension
Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 1 Month to 5 Months |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT06373289 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham, Alabama and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.