BPD Saturation TARgeting (BPD STAR)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

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

Treatments: Other: LOWER oxygen saturation target group; Other: HIGHER oxygen saturation target group

Study type: Interventional

Funder types: Other

Identifiers

NCT03385330

17-014522

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 34 to 44 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

LOWER oxygen saturation target group

Active Comparator group

Description:

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.

Treatment:

Other: LOWER oxygen saturation target group

HIGHER oxygen saturation target group

Active Comparator group

Description:

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.

Treatment:

Other: HIGHER oxygen saturation target group