NCT07120971EARLY_PHASE1Recruiting

Metformin for Premature Infants With Bronchopulmonary Dysplasia

Medical College of Wisconsin

Start Date

12/19/2025

Completion Date

9/1/2030

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?

Detailed Description

In Phase 0, there are four groups with different doses of metformin, starting at 5mg/kg/day to a maximum of 25mg/kg/day. Participants will take oral metformin twice a day for 3, 7 or 14 days, depending on which group they are in. In Phase 1, there are four groups with different doses of metformin, starting at 15mg/kg/day to a maximum of 25mg/kg/day. Participants will take oral metformin once a day for 3, 7, or 14 days, depending on what group they are in.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria Phase 0: * Birth gestational age of \< 29 weeks AND * Postnatal age between 8 and 22 weeks AND * Diagnosed with BPD at 36 weeks postnatal age Inclusion Criteria Phase 1: * 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 Criteria: * Persistent hypoglycemia * Lactic acidosis * Feeding intolerance * Renal or hepatic dysfunction * Active infection * Congenital anomalies that preclude feedings * Infants whose parents have chosen palliative care

Interventions

DRUG

Metformin (open-label)

DRUG

Metformin (open-label)

DRUG

Metformin (open-label)

DRUG

Metformin (open-label)

DRUG

Metformin (open-label)

DRUG

Metformin (open-label)

DRUG

Metformin (open-label)

DRUG

Metformin (open-label)

DRUG

Metformin (open-label)

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Conditions

Bronchopulmonary Dysplasia (BPD)

Locations

Children's Wisconsin

Milwaukee, Wisconsin 53226

United States