Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
University of Alabama at Birmingham
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.
Description
Infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and have mature retinas will be randomized to SpO2 targets of either (1) 92-95% (control) or (2) 95-98% (intervention). Using a cross over design with a 1:1 parallel allocation of infants randomized using a stratified permuted block design. Following 1week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period. Bedside providers will follow pre-specified algorithms to maintain oxygen targets during…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- Yes
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
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 BirminghamBirmingham, Alabama
- Yale New Haven HospitalNew Haven, Connecticut