Decreased Liver Kinase B1 Expression and Impaired Angiogenesis in a Murine Model of Bronchopulmonary Dysplasia.
Ujala Rana, Chintamani Joshi, Elijah Whitney...
https://pubmed.ncbi.nlm.nih.gov/38869353Actively Recruiting
Early Phase 1
Age: 7Days - 6Months
All Genders
ID07120971
A Phase 0/Phase 1 Trial of Metformin for Premature Infants With Bronchopulmonary Dysplasia
Led by Medical College of Wisconsin · Updated on 2026-01-26
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of metformin in reducing lung injury and supporting lung growth in premature infants diagnosed with bronchopulmonary dysplasia (BPD). This pilot study has two phases: Phase 0 focuses on safety and tolerance of oral metformin in older premature infants diagnosed with BPD at 36-44 weeks gestation, while Phase 1 evaluates safety and tolerance in extremely premature infants aged 7-30 days who are at higher risk for BPD. In Phase 0, participants receive different doses of oral metformin ranging from 5mg/kg/day to 25mg/kg/day, administered twice daily for periods of 3, 7, or 14 days depending on their assigned group. In Phase 1, metformin doses vary from 10mg/kg/day to 25mg/kg/day given once daily for 3, 7, or 14 days, with dose adjustments based on tolerance. The study uses multiple cohorts to explore these dosing schedules and tolerability. Participants will be closely monitored for their ability to tolerate metformin, including tracking treatment-related side effects such as metabolic acidosis, feeding problems, and respiratory deterioration for up to 14 days after the first dose. Pharmacokinetic evaluations will be completed, and researchers will also assess the incidence of complications related to prematurity such as necrotizing enterocolitis and retinopathy. The total participation time varies by cohort and duration of metformin administration.
CONDITIONS
Brief Title
Metformin for Premature Infants With Bronchopulmonary Dysplasia
Who Can Participate
Age: 7Days - 6Months
All Genders
Eligibility Criteria
You may qualify if you...
- Birth gestational age of less than 29 weeks
- For Phase 0: Postnatal age between 8 and 22 weeks and diagnosed with bronchopulmonary dysplasia at 36 weeks postnatal age
- For Phase 1: Postnatal age between 7 and 30 days and requiring mechanical ventilation or positive pressure support
You will not qualify if you...
- Persistent hypoglycemia
- Lactic acidosis
- Feeding intolerance
- Renal or hepatic dysfunction
- Active infection
- Congenital anomalies that prevent feeding
- Infants whose parents have chosen palliative care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 to 14 days
Participants receive oral metformin in varying doses and schedules depending on their assigned cohort, taking the medication once or twice daily for 3, 7, or 14 days.
Daily dosing with 1 to 14 days of medication depending on cohort
Follow-up
Duration - 14 days
Participants are monitored for treatment tolerance, adverse events, and clinical outcomes for 14 days after the first dose of metformin.
Follow-up visits during 14 days after treatment start
Trial Site Locations
Total: 1 location
1
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
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Research Team
K
Kathleen Meskin, BSN, RN, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
9
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Published Research Related To This Trial
Comparative Bioavailability and Pharmacokinetics Between the Solid Form of Metformin vs a Novel Liquid Extemporaneous Formulation in Children.
Radamés Alemón-Medina, Nelly Altamirano-Bustamante, Gustavo Lugo-Goytia...
https://pubmed.ncbi.nlm.nih.gov/34602916Use of Metformin in Pulmonary Vein Stenosis after TAPVR Repair.
Edward C Kirkpatrick, Michael E Mitchell, William G Thilly...
https://pubmed.ncbi.nlm.nih.gov/33029553Assessment of cognitive and neural recovery in survivors of pediatric brain tumors in a pilot clinical trial using metformin.
Ramy Ayoub, Rebecca M Ruddy, Elizabeth Cox...
https://pubmed.ncbi.nlm.nih.gov/32719487Metformin treatment in young children with fragile X syndrome.
Hazel Maridith B Biag, Laura A Potter, Victoria Wilkins...
https://pubmed.ncbi.nlm.nih.gov/31520524Mechanistic Phase II Clinical Trial of Metformin in Pulmonary Arterial Hypertension.
Evan L Brittain, Kevin Niswender, Vineet Agrawal...
https://pubmed.ncbi.nlm.nih.gov/33167773Metformin added to bosentan therapy in patients with pulmonary arterial hypertension associated with congenital heart defects: a pilot study.
Shutan Liao, Dongsheng Li, Zheng Hui...
https://pubmed.ncbi.nlm.nih.gov/30151369Dose-dependent immunomodulatory effects of metformin on human neonatal monocyte-derived macrophages.
Xuan Wang, Yijun Liu, Dongshan Han...
https://pubmed.ncbi.nlm.nih.gov/35679651Metformin improves obesity-associated inflammation by altering macrophages polarization.
Yuanyuan Jing, Fan Wu, Dai Li...
https://pubmed.ncbi.nlm.nih.gov/28935544Blood sample volumes in child health research: review of safe limits.
Stephen R C Howie
https://pubmed.ncbi.nlm.nih.gov/21346890