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NCT Number: NCT07120971

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?

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Key information

Conditions

Bronchopulmonary Dysplasia (BPD) Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

7 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

G. Ganesh Konduri, MD, MS

PRINCIPAL_INVESTIGATOR

Kathleen Meskin, BSN, RN, CCRP

CONTACT

[email protected]

414-337-7171

Ru-Jeng Teng, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin (open-label)

Drug

Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects

Primary outcomes

  1. Number of participants who tolerate metformin

    Time frame: 14 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

  2. Number of participants with treatment-related adverse events

    Time frame: 14 days after administration of the first dose of metformin

    Number of participants who develop hypoglycemia defined as blood glucose value <50

  3. Number of participants with treatment-related metabolic acidosis

    Time frame: 14 days after administration of the first dose of metformin

    Number of subjects who develop lactic acid levels > 5mmol/L

  4. Number of subjects with treatment-related feeding problems

    Time frame: 14 days after administration of the first dose of metformin

    Number of subjects who require a decrease in enteral feeding volume by >50% from baseline

  5. Number of subjects who require dose adjustments of metformin

    Time frame: 14 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

  6. Number of subjects with respiratory deterioration

    Time frame: 14 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

  7. Number of subjects who complete pharmacokinetic evaluation of metformin

    Time frame: 14 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

  8. Pharmacokinetic analysis of metformin

    Time frame: 14 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.

  9. Number of subjects who complete the treatment protocol

    Time frame: 14 days after administration of the first dose of metformin

    Number of subjects who complete the study doses of enteric metformin

Secondary outcomes

  1. Incidence of bronchopulmonary dysplasia

    Time frame: 14 days after administration of the first dose of metformin

    Number of subjects who are diagnosed with bronchopulmonary dysplasia

  2. Incidence of necrotizing enterocolitis

    Time frame: 14 days after administration of the first dose of metformin

    Number of subjects who are diagnosed with necrotizing enterocolitis

  3. Incidence of retinopathy of prematurity

    Time frame: 14 days after administration of the first dose of metformin

    Number of subjects who are diagnosed with retinopathy of prematurity

  4. Incidence of intraventricular hemorrhage

    Time frame: 14 days after administration of the first dose of metformin

    Number of subjects who are diagnosed with intraventricular hemorrhage

  5. Incidence of patent ductus arteriosus

    Time frame: 14 days after administration of the first dose of metformin

    Number of subjects who are diagnosed with patent ductus arteriosus

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Meskin, BSN, RN, CCRP

CONTACT

[email protected]

414-337-7171

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Aug 13, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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