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NCT06448780 · ClinicalTrials.gov registry record · Phase 1

Dose Optimization of Caffeine for HIE

A Phase 1 study of Hypoxic Ischemic Encephalopathy, sponsored by University of North Carolina, Chapel Hill.

Recruiting
Registry status
Phase 1
Development phase
16
Enrollment target
2
Study locations

NCT06448780 is a Phase 1 study of Hypoxic Ischemic Encephalopathy that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 16 participants, below the 82-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT06448780, a Phase 1 study of Hypoxic Ischemic Encephalopathy, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.

RECRUITING
Registry status
Phase 1
Development phase
16 participants
Enrollment target
2
Study locations

Study 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.

Conditions Studied

Hypoxic Ischemic Encephalopathy

Interventions

  • DRUG Caffeine citrate 20 mg/kg
  • DRUG Caffeine citrate 30 mg/kg

Study Locations (2)

North Carolina

  • The University of North Carolina at Chapel Hill Newborn Critical Care Center - Chapel Hill
  • Novant Health New Hanover Regional Medical Center - Wilmington

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2024-07-26
Est. Completion 2028-11
Phase Phase 1

Sponsor

University of North Carolina, Chapel Hill

1,109 total trials

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What the Registry Record Tells You About NCT06448780

The ClinicalTrials.gov registry entry for NCT06448780 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (80% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypoxic Ischemic Encephalopathy appearing as the primary indexed condition, and to 2 interventions - of which Caffeine citrate 20 mg/kg is the first listed.

NCT06448780 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT06448780 about?

NCT06448780 is a clinical study titled "Dose Optimization of Caffeine for HIE". This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.

What is the current status of trial NCT06448780?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-07-26. Estimated completion is 2028-11.

What conditions does trial NCT06448780 study?

This clinical trial studies the following conditions: Hypoxic Ischemic Encephalopathy.

What interventions are being tested in trial NCT06448780?

The interventions under investigation include: Caffeine citrate 20 mg/kg (DRUG), Caffeine citrate 30 mg/kg (DRUG).

Who is sponsoring clinical trial NCT06448780?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06448780 being conducted?

This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.