Clinical trial NCT03385330: BPD Saturation TARgeting
Official title: The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Chronic Lung Disease of Prematurity
Chronic Lung Disease
Keywords: BPD
Prematurity
Supplemental Oxygen
Oximetry
Infants
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2017-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 34
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time
timeFrame: Between discharge and 6 months corrected age
Secondary outcomes:
measure: Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80%
timeFrame: Between discharge and 6 months corrected age
measure: Change in Weight Z-score
timeFrame: Between randomization and 6 months corrected age
measure: Change in Length Z-score
timeFrame: Between randomization and 6 months corrected age
measure: Change in Head Circumference Z-score
timeFrame: Between randomization and 6 months corrected age
measure: Number of Participants With Re-hospitalization
timeFrame: Between discharge and 6 months corrected age
measure: Number of Participants With Respiratory Medication Use
timeFrame: At 6 months corrected age
measure: Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons
timeFrame: Between discharge and 6 months corrected age
measure: Feeding
timeFrame: At 6 months corrected age
measure: Development
timeFrame: At 6 months corrected age
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: The Childrens Hospital of Pennsylvania
name: Sara DeMauro, MD
role: PRINCIPAL_INVESTIGATOR
References: