The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 6
- Primary Endpoint
- Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time
Study Overview
Brief Summary
Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD. Participants will be randomly placed in either a higher oxygen saturation group or a lower oxygen saturation target group.
Detailed Description
Bronchopulmonary Dysplasia is diagnosed only in babies who are born prematurely, and affects about half of extremely preterm infants. The incidence of BPD has increased over time. It is most commonly defined as oxygen dependence at 36 weeks postmenstrual age (PMA).
Infants with BPD face more than doubled odds of death after 36 weeks PMA or disability at 5 years compared to preterm infants without BPD. BPD is associated with abnormal lung function throughout childhood and significantly increases health care costs. Cognitive and respiratory outcomes are closely linked throughout the life course; thus, optimal long--term management of BPD during infancy may ultimately improve cognitive outcomes of this high--risk population.
Supplemental oxygen is a lifesaving therapy for premature infants; yet, there is limited evidence about the safety or efficacy of using supplemental oxygen to target higher versus lower oxygen saturations in infants with established BPD.
Infants between the ages of 34-44 weeks post-menstrual age with moderate or severe BPD will be randomly assigned to higher or lower oxygen saturation target ranges. The study intervention will begin in the hospital and will continue at home until 6 months corrected age. When infants are discharged with supplemental oxygen, this will be titrated according to a study algorithm in order to ensure that the target saturations are maintained throughout the study period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 34 Weeks to 44 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time
Time Frame: Between discharge and 6 months corrected age
Incidence of intermittent hypoxia (IH, defined as SpO2 \<80% for \>=30 seconds), reported as median number of events per 8 hours of monitoring time.
Secondary Outcomes
- Change in Weight Z-score(Between randomization and 6 months corrected age)
- Number of Participants With Respiratory Medication Use(At 6 months corrected age)
- Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80%(Between discharge and 6 months corrected age)
- Number of Participants With Re-hospitalization(Between discharge and 6 months corrected age)
- Change in Length Z-score(Between randomization and 6 months corrected age)
- Change in Head Circumference Z-score(Between randomization and 6 months corrected age)
- Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons(Between discharge and 6 months corrected age)
- Feeding(At 6 months corrected age)
- Development(At 6 months corrected age)
Investigators
Sara B. DeMauro, MD MSCE
Assistant Professor of Pediatrics
Children's Hospital of Philadelphia