Bronchopulmonary Dysplasia Clinical Trials

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A Phase 0/Phase 1 Trial of Metformin for Premature Infants With Bronchopulmonary Dysplasia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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

Locations
United States
Wisconsin
Children's Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Kathleen Meskin, BSN, RN, CCRP
kmeskin@mcw.edu
414-337-7171
Time Frame
Start Date: 2025-12-19
Estimated Completion Date: 2030-09-01
Participants
Target number of participants: 40
Treatments
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)
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov