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

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05048550` - Babies in Glasses; a Feasibility Study.	N/A
Recruiting	`NCT05514340` - Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy	Phase 2
Recruiting	`NCT05836610` - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates	Phase 4
Completed	`NCT03024021` - Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Completed	`NCT01913340` - Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)	Phase 1/Phase 2
Enrolling by invitation	`NCT02260271` - Florida Neonatal Neurologic Network
Terminated	`NCT01192776` - Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)	N/A
Completed	`NCT06344286` - The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE	N/A
Recruiting	`NCT05901688` - Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
Recruiting	`NCT02894866` - Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy	N/A
Recruiting	`NCT03657394` - Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries	N/A
Recruiting	`NCT03682042` - Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up	N/A
Withdrawn	`NCT03681314` - Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)	N/A
Completed	`NCT03485781` - Propofol-induced EEG Changes in Hypoxic Brain Injury
Not yet recruiting	`NCT06429007` - A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury	Phase 2
Recruiting	`NCT05568264` - Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit	N/A
Completed	`NCT02264808` - Developmental Outcomes
Completed	`NCT05687708` - Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia	N/A
Recruiting	`NCT06195345` - Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
Withdrawn	`NCT05295784` - PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia	Phase 1