Actively Recruiting

Early Phase 1
Age: 7Days - 6Months
All Genders
NCT07120971

Metformin for Premature Infants With Bronchopulmonary Dysplasia

Led by Medical College of Wisconsin · Updated on 2026-01-26

40

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Metformin for Premature Infants With Bronchopulmonary Dysplasia

Who Can Participate

Age: 7Days - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Birth gestational age of less than 29 weeks and postnatal age between 8 and 22 weeks with a diagnosis of BPD at 36 weeks postnatal age (Phase 0)
  • Birth gestational age of less than 29 weeks, requiring mechanical ventilation or positive pressure support at 7 days postnatal age, and postnatal age between 7 and 30 days (Phase 1)
Not Eligible

You will not qualify if you...

  • Persistent hypoglycemia
  • Lactic acidosis
  • Feeding intolerance
  • Renal or hepatic dysfunction
  • Active infection
  • Congenital anomalies that prevent feedings
  • Infants whose parents have chosen palliative care

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

K

Kathleen Meskin, BSN, RN, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

9

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