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RECRUITING Not applicable ClinicalTrials.gov

Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

Sponsor: University of Alabama at Birmingham • ClinicalTrials.gov ID: NCT06373289

Registry updated: 2026-10-06
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Description

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.

Interventions

  • higher oxygen saturation target using Nellcor pulse oximetry sensors (Device)
    The intervention will be a cross over exposure to the higher oxygen saturation target.
  • lower oxygen saturation target using Nellcor pulse oximetry sensors (Device)
    The intervention will be a cross over exposure to the lower oxygen saturation target.

Eligibility 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

Conditions

Bronchopulmonary Dysplasia Pulmonary Hypertension

Locations

  • The University of Alabama at Birmingham — Birmingham, Alabama, United States
  • Yale New Haven Hospital — New Haven, Connecticut, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record