Metformin treatment for premature infants with bronchopulmonary dysplasia
A Phase 0/Phase 1 Trial of Metformin for Premature Infants With Bronchopulmonary Dysplasia
This study tests whether giving metformin to premature infants with bronchopulmonary dysplasia can reduce lung injury and help lungs grow.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 7 Days to 6 Months |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT07120971 on ClinicalTrials.gov |
What this trial studies
This is an open-label, early-phase pilot trial using dose-escalation cohorts to study safety and tolerance of oral metformin in very preterm infants at risk for or diagnosed with BPD. Phase 0 enrolls older premature infants (born <29 weeks, postnatal age 8–22 weeks with BPD at 36 weeks) and gives metformin twice daily across four dose groups (5–25 mg/kg/day) for 3, 7, or 14 days. Phase 1 enrolls extremely premature infants (born <29 weeks, 7–30 days old who require mechanical ventilation or positive pressure at day 7) and gives once-daily metformin across four dose groups (15–25 mg/kg/day) for 3, 7, or 14 days. The primary focus is safety and tolerability, with clinical monitoring for adverse events and feeding/ metabolic effects at a single site.
Who should consider this trial
Good fit: Ideal candidates are extremely premature infants born before 29 weeks who either have BPD at the 36-week assessment (Phase 0) or are 7–30 days old and still require respiratory support (Phase 1).
Not a fit: Infants with persistent hypoglycemia, lactic acidosis, feeding intolerance, significant renal or hepatic dysfunction, active infection, congenital anomalies preventing feeds, or those on palliative care are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, metformin could reduce lung injury and promote lung growth, potentially lowering BPD severity and the need for prolonged respiratory support.
How similar studies have performed: Using metformin to treat lung disease in premature infants is largely novel in humans, with limited clinical data but some supportive animal and preclinical studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milwaukee, Wisconsin
- Children's Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: G. Ganesh Konduri, MD, MS — Medical College of Wisconsin
- Study coordinator: Kathleen Meskin, BSN, RN, CCRP
- Email: kmeskin@mcw.edu
- Phone: 414-337-7171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.