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RECRUITINGINTERVENTIONAL

Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Major congenital anomalies Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

higher oxygen saturation target using Nellcor pulse oximetry sensors

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

DEVICE

lower 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