N/A
N=50
BPD Saturation TARgeting
Bronchopulmonary Dysplasia · Chronic Lung Disease of Prematurity · Chronic Lung Disease
Bottom Line
View on ClinicalTrials.gov: NCT03385330 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time — 2.2; 1.2 IH events per 8 hours of monitoring time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LOWER oxygen saturation target group (Other); HIGHER oxygen saturation target group (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time |
2.2; 1.2 | — |
| SECONDARY Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80% |
0.005; 0.004 | — |
| SECONDARY Change in Weight Z-score |
0.6; 0.5 | — |
| SECONDARY Change in Length Z-score |
1.7; 1.2 | — |
| SECONDARY Change in Head Circumference Z-score |
0.5; 0.4 | — |
| SECONDARY Number of Participants With Re-hospitalization |
9; 6 | — |
| SECONDARY Number of Participants With Respiratory Medication Use |
6; 6 | — |
| SECONDARY Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons |
5; 2 | — |
| SECONDARY Feeding |
1; 0 | — |
| SECONDARY Development |
8; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03385330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.