Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
Recruiting · NCT06373289 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
higher oxygen saturation target using Nellcor pulse oximetry sensorslower oxygen saturation target using Nellcor pulse oximetry sensors
What this trial is about
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 can take part
Age range
1 Month to 5 Months
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 2 US states.
- The University of Alabama at Birmingham - Birmingham, Alabama, United States
- Yale New Haven Hospital - New Haven, Connecticut, United States