Metformin for Premature Infants With Bronchopulmonary Dysplasia

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?

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.

Sponsors & Collaborators

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• G. Ganesh Konduri, MD, MS · Medical College of Wisconsin

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

7 Days

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-19

Primary Completion

2028-09-01

Completion

2030-09-01

FDA Drug

Yes

Countries

• United States

Study Locations