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Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

RecruitingNAAges 1 Month - 5 MonthsAllUniversity of Alabama at Birmingham
NCT06373289 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • higher oxygen saturation target using Nellcor pulse oximetry sensors
  • lower oxygen saturation target using Nellcor pulse oximetry sensors
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Where

2 sites
The University of Alabama at Birmingham
Birmingham, United States
Yale New Haven Hospital
New Haven, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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