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Tiny babies, big challenge: new pain scale for preemies born before 27 weeks

NCT ID NCT07481331

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de la Réunion 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study aims to develop a new pain assessment scale, called EDEX, specifically for extremely premature infants born before 27 weeks. Current scales may not work well for these fragile babies, who show pain in subtle ways. Researchers will create the scale and then test it against an existing scale in 68 infants in a neonatal intensive care unit.

What this could mean

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

What this could lead to
If successful, this could lead to a more accurate tool for measuring pain in the tiniest premature babies, helping doctors and nurses provide better comfort care.
What could go wrong
This is a very early, small observational study (68 infants) at a single hospital. The new scale may not work better than existing ones, and further validation will be needed before it can be widely used.

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.

Participants

About 68 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 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.

Who is studied

Extremely premature infants(\< 27 weeks of amenorrhea) hospitalised in neonatal intensive care at University Hospital Centre of Reunion Island

Ages

Up to 27 weeks

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: Extremely premature infants: * born before 27 weeks of gestation, and aged no more than 26 weeks of amenorrhea + 6 days in corrected age, * from 48 hours of life, * hospitalised in neonatal intensive care, * for whom at least one of the two legal guardians has given their consent. Exclusion Criteria: Extreme premature infants: * whose clinical condition is critical with a risk of imminent death, * with major brain damage (HIV 4) or major brain malformations, * deeply sedated or paralyzed with no spontaneous reactions, * whose parents are both minors. * who are not already participating in another study.

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Conditions

The condition(s) this trial relates to.

Pain respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Discomfort symptoms Extremely premature infant Pain

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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