Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448780
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-03
Brief Title:
Dose Optimization of Caffeine for HIE
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23HD111623-01 | NIH | None | httpsreporternihgovquickSearch1K23HD111623-01 |