BPD Saturation TARgeting

Not Applicable

Completed

Conditions: Chronic Lung Disease of Prematurity
Bronchopulmonary Dysplasia
Chronic Lung Disease

Interventions: Other: HIGHER oxygen saturation target group
Other: LOWER oxygen saturation target group

Registration Number: NCT03385330

Lead Sponsor: Children's Hospital of Philadelphia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIGHER oxygen saturation target group	HIGHER oxygen saturation target group	Oxygen saturation target range greater than or equal to 96%.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.
LOWER oxygen saturation target group	LOWER oxygen saturation target group	Oxygen saturation (SpO2) target range 90--94%. The study intervention will begin in the hospital and will continue at home until 6 months corrected age (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.

Primary Outcome Measures

Name	Time	Method
Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time	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 Outcome Measures

Name	Time	Method
Change in Weight Z-score	Between randomization and 6 months corrected age	Change in weight Z-score. A Z-score of 0 represents average weight. Positive change in Z score indicates increasing weight relative to the population average weight. Negative change in Z score indicates decreasing weight relative to the population average weight.
Number of Participants With Respiratory Medication Use	At 6 months corrected age	Number of patients with inhaled respiratory medication use
Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80%	Between discharge and 6 months corrected age	Total exposure to hypoxia - proportion of monitored time with SpO2 \<80%
Number of Participants With Re-hospitalization	Between discharge and 6 months corrected age	Any re-hospitalization
Change in Length Z-score	Between randomization and 6 months corrected age	Change in length Z-score. A Z-score of 0 represents average length. Positive change in Z score indicates increasing length relative to the population average length. Negative change in Z score indicates decreasing length relative to the population average length.
Change in Head Circumference Z-score	Between randomization and 6 months corrected age	Change in head circumference (HC) Z-score. A Z-score of 0 represents average HC. Positive change in Z score indicates increasing HC relative to the population average HC. Negative change in Z score indicates decreasing HC relative to the population average HC.
Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons	Between discharge and 6 months corrected age	Any visits to ER or urgent care for respiratory health-related problems
Feeding	At 6 months corrected age	Quality of infant oral feeding skills, parent reports that the child's feeding times are stressful or very stressful for themselves
Development	At 6 months corrected age	Bayley Scales of Infant Development screening test, which is a standardized assessment of cognitive, motor, and language development in infancy and early childhood. Outcome will be reported as number of children considered "at risk" in any domain.

Trial Locations

Locations (3): University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
🇺🇸
Philadelphia, Pennsylvania, United States