BPD Saturation TARgeting

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.

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

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

- Respiratory support > 2L nasal cannula during entire eligibility period