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Caffeine dosing study for newborns with HIE aims to improve safety

NCT ID NCT06448780

Knowledge-focused Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study looks at how caffeine is processed in newborns with hypoxic-ischemic encephalopathy (HIE), a brain injury caused by lack of oxygen, who are receiving cooling therapy. Researchers will test different doses of caffeine in 16 babies to find the safest and most effective amount. The goal is to better understand how to use caffeine to help these newborns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 24 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented informed consent from parent or guardian * ≥ 36 weeks gestational age at birth * Receiving therapeutic hypothermia for a diagnosis of HIE * Intravenous (IV) access * Postnatal age \< 24 hours Exclusion Criteria: * Receiving \> 1 anti-epileptic drug for seizures * Sustained (\>4 hours) heart rate \> 180 beats per minute * Known major congenital anomaly

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoxic-ischemic encephalopathy

Contacts and locations

Locations

  • Novant Health New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401, United States

  • The University of North Carolina at Chapel Hill Newborn Critical Care Center

    Chapel Hill, North Carolina, 27599, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.