Safety and feasibility trial protocol of metformin in infants after perinatal brain injury.

ABSTRACT:

Introduction

Infants with hypoxic-ischaemic encephalopathy (HIE) are at a high risk for neurodevelopmental impairment, and adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognised as a neurorestorative agent, but, to date, has not been used in infants. Herein, we describe a clinical trial of the safety, feasibility and pharmacokinetics of metformin in infants with HIE.  METHODS AND ANALYSIS: In collaboration with patient and family stakeholders, we designed a pragmatic clinical trial. To determine appropriate dosing of metformin, we performed physiologically based pharmacokinetic (PBPK) modelling after scaling a published adult PBPK model of metformin to an infant population of full-term newborns to 3-month-olds. Based o

SUBMITTER: Hutchinson AM 

PROVIDER: S-EPMC12382569 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature