Metformin for Premature Infants with Bronchopulmonary Dysplasia
This study is investigating metformin to see if it can help reduce lung injury and promote lung growth in premature infants. Researchers want to understand how well premature infants tolerate metformin and if it's safe for them. The study is open to premature infants between 7 days and 6 months old who have or are at high risk for bronchopulmonary dysplasia (BPD), a chronic lung condition. Success in this study means participants tolerate metformin well, have few treatment-related side effects, and do not develop a specific metabolic issue called metabolic acidosis. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 40 participants. It is an open-label study, meaning both you and your care team will know you are receiving metformin.
- What's involved
- Participants will receive oral metformin once or twice daily for 3, 7, or 14 days, depending on their assigned group.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for 14 days after their first dose of metformin to check for tolerance and side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Metformin for Premature Infants With Bronchopulmonary Dysplasia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- G. Ganesh Konduri, MD, MS · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Number of participants who tolerate metformin14 days after administration of the first dose of metformin
Number of subjects who receive enteral doses of metformin and complete the study days without an adverse event while continuing enteral feedings
- Number of participants with treatment-related adverse events14 days after administration of the first dose of metformin
Number of participants who develop hypoglycemia defined as blood glucose value \<50
- Number of participants with treatment-related metabolic acidosis14 days after administration of the first dose of metformin
Number of subjects who develop lactic acid levels \> 5mmol/L
- Number of subjects with treatment-related feeding problems14 days after administration of the first dose of metformin
Number of subjects who require a decrease in enteral feeding volume by \>50% from baseline
- Number of subjects who require dose adjustments of metformin14 days after administration of the first dose of metformin
Number of subjects who need decreases in dose or discontinuation of metformin due to hepatic or renal dysfunction
- Number of subjects with respiratory deterioration14 days after administration of the first dose of metformin
Number of subjects who develop pneumonia and increases in oxygen concentration and ventilator support during the study
- Number of subjects who complete pharmacokinetic evaluation of metformin14 days after administration of the first dose of metformin
Number of subjects who have at least one metformin concentration in blood measured at 1, 4 and 12 hours after an enteric dose
- Pharmacokinetic analysis of metformin14 days after administration of the first dose of metformin
Area under the curve of Plasma Concentration Versus Time (AUC) of metformin over a time frame of 1, 4 and 12 hours after an enteric dose of metformin.
- Number of subjects who complete the treatment protocol14 days after administration of the first dose of metformin
Number of subjects who complete the study doses of enteric metformin