BPD Saturation TARgeting (BPD STAR)
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring BPD, Prematurity, Supplemental Oxygen, Oximetry, Infants
Eligibility Criteria
Inclusion Criteria:
- Pre-term males or females infants born at <30 0/7 weeks gestation at birth
- Current age 34 0/7 to 43 6/7 weeks postmenstrual age
- Diagnosis of moderate or severe Bronchopulmonary Dysplasia based on the NIH consensus definition
- Infant has never been discharged to home from the hospital
Exclusion Criteria:
- Congenital anomaly or oncologic process likely to affect growth or respiratory status
- Hemoglobinopathy or other blood disorder likely to affect oxygen saturations
- Contraindication to nasal cannula use (for example, severe nasal septal breakdown).
- Pulmonary hypertension requiring pharmacotherapy at the time of screening/enrollment.
- Tracheostomy
- Intubated during entire eligibility period
Sites / Locations
- Children's Hospital of Philadelphia
- University of Pennsylvania
- Pennsylvania Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
LOWER oxygen saturation target group
HIGHER oxygen saturation target group
Oxygen saturation target range 90--94%. The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm.
Oxygen saturation target range greater than or equal to 96%.The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm.