Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorUniversity of Alabama at Birmingham
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Major congenital anomalies
Trial design
Treatments tested in this trial
- higher oxygen saturation target using Nellcor pulse oximetry sensors
- lower oxygen saturation target using Nellcor pulse oximetry sensors
Treatment groups
39 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Yale University
Sponsor institution
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov