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Metformin for Premature Infants With Bronchopulmonary Dysplasia

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

Who can join

7 Days – 6 Months · All sexes

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

About the study

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?

What is being tested

• Metformin (open-label) (drug)
• Metformin (open-label) (drug)
• Metformin (open-label) (drug)
• Metformin (open-label) (drug)
• Metformin (open-label) (drug)
• Metformin (open-label) (drug)

Sponsor: Medical College of Wisconsin · Participants: 40 · Started: Dec 19, 2025

Contact the study team

• Kathleen Meskin, BSN, RN, CCRP · Phone: 414-337-7171

Official record on ClinicalTrials.gov — NCT07120971

Locations in the U.S.

Conditions

• Bronchopulmonary Dysplasia
• Premature Birth

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.