Could melatonin help save newborn brains after oxygen deprivation?
NCT ID NCT07652801
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding melatonin to standard magnesium sulfate treatment improves recovery in full-term newborns with hypoxic-ischemic encephalopathy (HIE), a brain injury caused by oxygen deprivation at birth. Eighty babies will be split into two groups: one gets magnesium sulfate alone, the other gets magnesium sulfate plus five doses of melatonin. Researchers will measure changes in blood acidity and a marker of cell damage, as well as how long babies stay in the hospital and how soon they can start feeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- melatonin and magnesium sulfate
- What this could lead to
- If it works, this combination could reduce brain damage and shorten hospital stays for newborns with oxygen deprivation at birth.
- What could go wrong
- This is a small, early-phase trial with only 80 babies, so results may not apply widely. Melatonin's safety in newborns is still being studied.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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1 hour to 28 days
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Both genders * Born at term i.e \>37weeks gestation * With APGAR score\<5 at 1min * Umblical artery acidemia(PH\<7 or base deficit\>12mmol/L * Evidence of atleast moderate grade ofHIE on sarnat scoring. Exclusion Criteria: * With congenital anamolies * Intrauterine growth retadation * suspicion of neonatal sepsis * Congenital heart disese and those with IEM.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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