Dose Optimization of Caffeine for HIE

Status Not yet recruiting

Clinical Trial Summary

This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.

Clinical Trial Description

In a previous phase I trial (NCT03913221), the investigators characterized the pharmacokinetics (PK) of caffeine in the setting of HIE and therapeutic hypothermia using a population PK model. This is an open-label study of caffeine citrate in neonates with HIE to validate the population PK model and determine optimal dosing for HIE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06448780
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact	Wesley M Jackson, MD, MPH
Phone	984-215-3449
Email	wesley.jackson@unc.edu
Status	Not yet recruiting
Phase	Phase 1
Start date	November 2024
Completion date	November 2028

View Details

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