Metformin for Premature Infants With Bronchopulmonary Dysplasia

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 1, 2028

Study Completion Date

September 1, 2030

Conditions
Bronchopulmonary Dysplasia (BPD)
Interventions
DRUG

Metformin (open-label)

Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects

DRUG

Metformin (open-label)

Enteric metformin 10mg/kg/day in two divided doses will be given for three days to two subjects.

DRUG

Metformin (open-label)

Enteric metformin 20mg/kg/day in two divided doses will be given for seven days to three subjects.

DRUG

Metformin (open-label)

Enteric metformin 25mg/kg/day in two divided doses will be given for 14 days to three subjects.

DRUG

Metformin (open-label)

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)

DRUG

Metformin (open-label)

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)

DRUG

Metformin (open-label)

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.

DRUG

Metformin (open-label)

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.

DRUG

Metformin (open-label)

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.

Trial Locations (1)

53226

Children's Wisconsin, Milwaukee

All Listed Sponsors
lead

Medical College of Wisconsin

OTHER