Metformin treatment for premature infants with bronchopulmonary dysplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Enteral DHA and ARA Supplementation for Very Preterm Infants with BPD Risk

  This study tests whether giving a specific mix of DHA and ARA through feeding helps prevent bronchopulmonary dysplasia in extremely and very preterm babies.

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• Long-term impact of BPD on parents and caregivers (BronQ Family)

  This project will see how having a child who had bronchopulmonary dysplasia (BPD) affects parents' and caregivers' quality of life and family burden across several countries using an online questionnaire.

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• Does early red blood cell transfusion affect complications and neurodevelopment in premature infants?

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• Montelukast for critically ill premature infants developing bronchopulmonary dysplasia: pharmacokinetics, safety, and early efficacy

  This study gives once-daily montelukast to critically ill premature infants developing bronchopulmonary dysplasia to test how the drug moves through the body, whether it is safe, and whether it helps breathing.

  Recruiting at 5 sites Phase 1/2 Duke University · Little Rock, Arkansas and 4 other locations · NCT07101640

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.