Metformin for Premature Infants With Bronchopulmonary Dysplasia
A Phase 0/Phase 1 Trial of Metformin for Premature Infants With Bronchopulmonary Dysplasia
Medical College of Wisconsin
40 participants
Dec 19, 2025
INTERVENTIONAL
Conditions
Summary
The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study. For Phase 0, the goal is to investigate the safety and tolerance of oral metformin in premature who have been diagnosed with bronchopulmonary dysplasia (BPD) at 36-44 weeks gestation. For Phase 1, the goal is to investigate metformin safety and tolerance in extremely premature infants who are 7-30 days old who have an increased risk of BPD. The main questions it aims to answer are: * how well do older premature infants tolerate metformin? * how well do younger premature infants tolerate metformin?
Eligibility
Inclusion Criteria6
- Birth gestational age of \< 29 weeks AND
- Postnatal age between 8 and 22 weeks AND
- Diagnosed with BPD at 36 weeks postnatal age
- Birth gestational age of \< 29 weeks, AND
- Requiring mechanical ventilation or positive pressure support at 7 days postnatal age, AND
- Postnatal age between 7 and 30 days
Exclusion Criteria7
- Persistent hypoglycemia
- Lactic acidosis
- Feeding intolerance
- Renal or hepatic dysfunction
- Active infection
- Congenital anomalies that preclude feedings
- Infants whose parents have chosen palliative care
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Interventions
Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects
Enteric metformin 10mg/kg/day in two divided doses will be given for three days to two subjects.
Enteric metformin 20mg/kg/day in two divided doses will be given for seven days to three subjects.
Enteric metformin 25mg/kg/day in two divided doses will be given for 14 days to three subjects.
Enteric metformin 15mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, the next Cohort will increase to 25mg/kg/day (Cohort 2) or decrease to 10mg/kg/day (Cohort 3)
Enteric metformin 25mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 25mg/kg/day or 15mg/kg/day will be dose selected for the next Cohort (Cohort 4)
Enteric metformin 10mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 10mg/kg/day dose selected for the next Cohort (Cohort 4) or the study will be stopped due to excessive toxicity.
The dose for this cohort will be selected from either Cohort 2 or 3 based on tolerance. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for seven days to 6 subjects.
The dose for this cohort will be the same as Cohort 4. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for 14 days to 6 subjects.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07120971