A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury

Infant Development Clinical Trial

Official title:

A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429007
• Other study ID #: IRB-P00048370
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: May 2024
• Source: Boston Children's Hospital
• Contact: Vanessa Young, MS, RN
• Phone: 617-355-8330
• Email: Vanessa.young[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 6 Months

Eligibility

Inclusion Criteria:

• Infants born > 35 weeks' gestational age AND

• Received therapeutic hypothermia for clinically diagnosed HIE

Exclusion Criteria:

• Infants with known genetic or chromosomal disorders

• Infants with a liver or kidney disease that may affect drug metabolism

• Maternal metformin use while actively breastfeeding

• Infant weight is below the 10th percentile (as defined by World Health Organization) at time of study drug initiation.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Ischemia
• HIE
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Infant Development
• Neurodevelopment

Intervention

Drug:
• Metformin
Infants in the study will receive 50% of the target dose (12.5mg/kg) for the first 6 weeks of participation. At the 6 week visit, the patient will be assessed and if found still eligible, will receive the full dose (25mg/kg) for the remaining 6 weeks of participation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of kidney function	A renal function panel (chem 10 with renal function) will be performed prior to the initiation of therapy and at all subsequent study visits.	12 weeks
Primary	Safety profile of liver function	A liver function test (LFT) will be performed prior to the initiation of therapy and at all subsequent study visits.	12 weeks
Primary	Recruitment feasibility	To assess feasibility, the number of eligible patients will be compared to the number of patients who consent to participate in the study.	12 weeks
Secondary	Validity of neonatal model of metformin pharmacokinetics	Plasma metformin levels will be analyzed by investigators with whole blood obtained at study visits.	12 weeks
Secondary	Stakeholder Satisfaction	Parents/caregivers will be sent a survey that utilizes a 5 point Likert scale to assess key factors that prevented or encouraged participation.	12 weeks