Study of Metformin to Help Premature Infants With Bronchopulmonary Dysplasia Testing Safety and Tolerance in Different Age Groups

What this Trial Is About

Researchers are investigating the role of metformin in reducing lung injury and supporting lung growth in premature infants diagnosed with bronchopulmonary dysplasia BPD. This pilot study has two phases Phase 0 focuses on safety and tolerance of oral metformin in older premature infants diagnosed with BPD at 36-44 weeks gestation, while Phase 1 evaluates safety and tolerance in extremely premature infants aged 7-30 days who are at higher risk for BPD. In Phase 0, participants receive different doses of oral metformin ranging from 5mgkgday to 25mgkgday, administered twice daily for periods of 3, 7, or 14 days depending on their assigned group. In Phase 1, metformin doses vary from 10mgkgday to 25mgkgday given once daily for 3, 7, or 14 days, with dose adjustments based on tolerance. The study uses multiple cohorts to explore these dosing schedules and tolerability. Participants will be closely monitored for their ability to tolerate metformin, including tracking treatment-related side effects such as metabolic acidosis, feeding problems, and respiratory deterioration for up to 14 days after the first dose. Pharmacokinetic evaluations will be completed, and researchers will also assess the incidence of complications related to prematurity such as necrotizing enterocolitis and retinopathy. The total participation time varies by cohort and duration of metformin administration.

Metformin for Premature Infants With Bronchopulmonary Dysplasia