Actively Recruiting
Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
Led by University of Alabama at Birmingham · Updated on 2026-03-27
39
Participants Needed
2
Research Sites
221 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.
CONDITIONS
Official Title
Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born between 22 weeks 0 days and 31 weeks 6 days gestation
- Diagnosed with pulmonary hypertension by echocardiogram showing either >20% blood flow across PDA from pulmonary to arterial circulation, end-systolic flattening of the interventricular septum (eccentricity index >1.3), or right ventricular pressure ≥ 35 mm Hg
- Receiving supplemental oxygen
- Have mature retinas
You will not qualify if you...
- Major congenital anomalies
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
S
Samuel Gentle, MD
CONTACT
C
Colm Travers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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