Metformin for Premature Infants With Bronchopulmonary Dysplasia

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07120971
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia (BPD)

Eligibility Criteria

Sex
ALL
Age
7 Days - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • Metformin (open-label) — DRUG
    Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects
  • Metformin (open-label) — DRUG
    Enteric metformin 10mg/kg/day in two divided doses will be given for three days to two subjects.
  • Metformin (open-label) — DRUG
    Enteric metformin 20mg/kg/day in two divided doses will be given for seven days to three subjects.
  • Metformin (open-label) — DRUG
    Enteric metformin 25mg/kg/day in two divided doses will be given for 14 days to three subjects.
  • Metformin (open-label) — DRUG
    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)
  • Metformin (open-label) — DRUG
    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)
  • Metformin (open-label) — DRUG
    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.
  • Metformin (open-label) — DRUG
    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.
  • Metformin (open-label) — DRUG
    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.

Study Details

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?

Key Dates

Start date
Dec 19, 2025
Status verified
Jan 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Phase 0 - Cohort 1
    5mg/kg/day in two divided doses for three days
  • Experimental: Phase 0 - Cohort 2
    10mg/kg/day in two divided doses for three days
  • Experimental: Phase 0 - Cohort 3
    20mg/kg/day in two divided doses for seven days
  • Experimental: Phase 0 - Cohort 4
    25mg/kg/day in two divided doses for 14 days
  • Experimental: Phase 1 - Cohort 1 Escalation
    15mg/kg/day in a single daily dose for three days
  • Experimental: Phase 1 - Cohort 2 Escalation
    25mg/kg/day in a single daily dose for three days
  • Experimental: Phase 1- Cohort 3 Escalation
    10mg/kg/day in a single daily dose for three days
  • Experimental: Phase 1 - Cohort 4 Expansion
    10-25mg/kg/day (dose selected from either Cohort 2 or 3)
  • Experimental: Phase 1 - Cohort 5 Expansion
    10-25mg/kg/day (dose selected from either Cohort 2 or 3)

Primary Outcome Measure

Number of participants who tolerate metformin [ Time Frame: 14 days after administration of the first dose of metformin ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's WisconsinMilwaukeeWisconsin53226
Kathleen Meskin, BSN, RN, CCRP
[email protected]
414-337-7171
G. Ganesh Konduri, MD, MS (PRINCIPAL_INVESTIGATOR)
Ru-Jeng Teng, MD (SUB_INVESTIGATOR)

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Children's Wisconsin· Milwaukee, WI

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