NCT07120971 Metformin for Premature Infants With Bronchopulmonary Dysplasia
| NCT ID | NCT07120971 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Medical College of Wisconsin |
| Condition | Bronchopulmonary Dysplasia (BPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-12-19 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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?
Eligibility 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
Contact & Investigator
G. Ganesh Konduri, MD, MS
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT07120971 clinical trial?
This trial is open to participants of all sexes, aged 7 Days or older, up to 6 Months, studying Bronchopulmonary Dysplasia (BPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07120971 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07120971 currently recruiting?
Yes, NCT07120971 is actively recruiting participants. Contact the research team at kmeskin@mcw.edu for enrollment information.
Where is the NCT07120971 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT07120971 clinical trial?
NCT07120971 is sponsored by Medical College of Wisconsin. The principal investigator is G. Ganesh Konduri, MD, MS at Medical College of Wisconsin. The trial plans to enroll 40 participants.