Metformin for Premature Infants With Bronchopulmonary Dysplasia

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

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?

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.

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