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RECRUITING Phase 1

Dose Optimization of Caffeine for HIE

NCT06448780 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06448780

The ClinicalTrials.gov registry entry for NCT06448780 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06448780 reports 2 study locations spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06448780?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial