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RecruitingNCT06373289

Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

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Trial Parameters

ConditionBronchopulmonary Dysplasia
SponsorUniversity of Alabama at Birmingham
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment39
SexALL
Min Age1 Month
Max Age5 Months
Start Date2026-04
Completion2029-07-01
Interventions
higher oxygen saturation target using Nellcor pulse oximetry sensorslower oxygen saturation target using Nellcor pulse oximetry sensors

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Brief 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 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

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