Brief Title
BPD Saturation TARgeting
Official Title
The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial
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 Type
Interventional
Primary Outcome
Intermittent hypoxemia (IH)
Secondary Outcome
Duration of hypoxia
Condition
Bronchopulmonary Dysplasia
Intervention
LOWER oxygen saturation target group
Study Arms / Comparison Groups
LOWER oxygen saturation target group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
50
Start Date
June 1, 2018
Completion Date
February 1, 2022
Primary Completion Date
February 1, 2021
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
Gender
All
Ages
34 Weeks - 44 Weeks
Accepts Healthy Volunteers
No
Contacts
Sara DeMauro, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03385330
Organization ID
17-014522
Responsible Party
Principal Investigator
Study Sponsor
Children's Hospital of Philadelphia
Collaborators
Thrasher Research Fund
Study Sponsor
Sara DeMauro, MD, Principal Investigator, The Childrens Hospital of Pennsylvania
Verification Date
April 2020