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Could melatonin help save Babies' brains after birth injury?

NCT ID NCT07305350

Disease control Sponsor: University of Child Health Sciences and Children's Hospital, Lahore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving melatonin to full-term newborns with hypoxic-ischemic encephalopathy (HIE) — a type of brain injury from lack of oxygen at birth — can improve survival and reduce brain damage. Half of the 110 babies will receive a single dose of melatonin through a feeding tube plus standard care, while the other half gets standard care alone. Researchers will check survival at 28 days and brain injury scores at days 1, 3, and 7.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin
What this could lead to
If it works, this could point toward a simple, safe treatment to improve survival and reduce brain damage in newborns with HIE.
What could go wrong
This is a small, early-phase trial with only 110 babies, so results may not be definitive. Melatonin's benefit is unproven, and standard care already includes intensive monitoring.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

110 people

The number who actually took part.

Started

Dec 2025

Expected to finish

May 2026

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

1 hour and older

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: All term infants (as per operational definition). Both genders. Presenting with hypoxic ischemic encephalopathy (as per operational definition). Exclusion criteria: Drug reactions. Newborns at gestational age \< 36 weeks. Neonates whose mother received general anesthesia. Neonates with congenital malformations. Neonates whose mother received anticonvulsants. Neonates not fulfilling criteria for HIE. Neonatal sepsis, pneumonia or in-born error of metabolism.

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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 ischaemic encephalopathy (HIE)

Contacts and locations

Locations

  • Children Hospital and University of Child Health Sciences, Lahore

    Lahore, Punjab Province, 05411, Pakistan

More trials for these conditions

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