Project Details

E.W. "Al" Thrasher

Status: Funded - Open

The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial

Sara DeMauro, MD, MSCE

Summary

BACKGROUND: Bronchopulmonary dysplasia (BPD) affects nearly half of surviving extremely preterm (<28 weeks gestational age) infants, and these infants have greater than doubled odds of death after 36 weeks postmenstrual age or disability up to 5 years. The risks and benefits of targeting different oxygen saturation (SpO2) levels (and thereby reducing intermittent hypoxemia (IH)) have been evaluated extensively in preterm infants during the initial hospitalization, but have not been studied in infants with established lung disease as they approach term corrected age or after they have been discharged home.

GAP: No controlled studies have described continuous oxygen saturation monitoring for infants with established BPD or evaluated the safety and efficacy of targeting higher versus lower saturations for reducing IH and improving outcomes of infants with established BPD.

HYPOTHESES:

• Infants randomized to a lower SpO2 target will have more IH and total duration of hypoxia throughout the study period.

• Infants randomized to a higher SpO2 target will have improved development, growth, and feeding without adverse impact on health care utilization or quality of life.

METHODS: In this pilot randomized clinical trial, preterm-born infants who remain on respiratory support at 34-44 weeks PMA will be randomized to higher or lower SpO2 target ranges, which will be maintained until 6 months corrected age. We will enroll 42 participants in this pilot study to detect a 30% reduction in IH in the high target group with 80% power.

RESULTS: Pending.

IMPACT: The proposed study will generate critical pilot data necessary to scale up our novel and low-cost monitoring device and to inform development of a larger multicenter clinical trial that will assess the impact of home oxygen use and SpO2 targeting on clinically relevant developmental outcomes at to two years corrected age in this high-risk population.