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Can melatonin stop baby colic? new trial aims to find out

NCT ID NCT07442162

Symptom relief Sponsor: Al-Hadba university 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether melatonin drops can reduce excessive crying in newborns with colic. 165 babies aged 14-20 days who cry more than 3 hours a day will get either melatonin or a placebo for 28 days. Parents will track crying times. The goal is to see if melatonin is a safe and effective option for infant colic.

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 offer a safe option to reduce colic-related crying in newborns, easing parent anxiety.
What could go wrong
This is an early-phase trial with a small sample. Melatonin may not work better than placebo, and safety in newborns is not yet fully known.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 165 people

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

Started

Feb 2026

Expected to finish

Apr 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

14 to 28 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: neonates with excessive crying, of more than 3 hours/day duration of crying, on more than 3 days per week, who are otherwise healthy without any apparent complications. \- Exclusion Criteria: neonates with major birth complications, neurological disorders or medical pathology. \-

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Conditions

The condition(s) this trial relates to.

Crying

As listed by the trial registrant

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

CRYING

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Al-hadba university

    Mosul, Nineveh Governorate, 41, Iraq

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