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Metformin for Premature Infants With Bronchopulmonary Dysplasia

RecruitingEARLY Phase 1Ages 7 Days - 6 MonthsAllMedical College of Wisconsin
NCT07120971 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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?

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📋 Eligibility rules (as published)
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
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What it tests

  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
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Where

1 site
Children's Wisconsin
Milwaukee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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