Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could melatonin help save newborn brains after oxygen loss?

NCT ID NCT02621944

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 30, 2026 · Updated 2 times

Summary

This early-phase study tests whether adding melatonin to standard cooling therapy can improve brain outcomes in newborns with hypoxic-ischemic encephalopathy (HIE), a condition caused by oxygen loss at birth. About 70 full-term infants will receive different doses of melatonin to find the safest and most effective amount. The goal is to reduce brain damage and improve development as the child grows.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 70 people

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

Started

Nov 2016

Expected to finish

Mar 2027

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 6 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: * Eligible infants are \>36 0/7th weeks gestation, * pH (cord or neonatal) \<7.0, * base deficit \>16 mEq/L, * no available blood gas, * a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15, * base deficit between 10 and 15.9 mEq/L, * infants must have a history of an acute perinatal event, * either a 10-minute Apgar \< 5 or a continued need for ventilation, * All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system, * neonates cooled within 6 hours of birth will be included in the study. Exclusion Criteria: * suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia, * clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation, * a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypoxic-ischemic encephalopathy are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Florida Hospital for Children

    RECRUITING

    Orlando, Florida, 32803, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

More trials for these conditions

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