RecruitingNot ApplicableNCT06373289

Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension


Sponsor

University of Alabama at Birmingham

Enrollment

39 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 MonthMax Age: 5 Months

Inclusion Criteria4

  • 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 Criteria1

  • Major congenital anomalies

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Interventions

DEVICEhigher oxygen saturation target using Nellcor pulse oximetry sensors

The intervention will be a cross over exposure to the higher oxygen saturation target.

DEVICElower oxygen saturation target using Nellcor pulse oximetry sensors

The intervention will be a cross over exposure to the lower oxygen saturation target.


Locations(2)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

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NCT06373289


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