Status:
COMPLETED
BPD Saturation TARgeting
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Bronchopulmonary Dysplasia
Chronic Lung Disease of Prematurity
Eligibility:
All Genders
34-44 years
Phase:
NA
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 es...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03385330
Start Date
June 1 2018
End Date
September 1 2023
Last Update
April 30 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107