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New device could help measure pain in tiniest babies

NCT ID NCT05223790

Knowledge-focused Sponsor: University Hospital, Lille 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a device called NIPE that measures heart rate changes to detect pain in very premature babies (born before 34 weeks) who are sedated and on ventilators. Researchers compared NIPE readings before and during care procedures in 50 infants. The goal was to see if this monitor can reliably assess pain and discomfort in this vulnerable group.

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 better way to measure pain in premature babies who cannot speak, helping doctors adjust care more precisely.
What could go wrong
This is a small, early study with only 50 babies. The NIPE monitor may not prove reliable enough for routine use, and results may not apply to all preterm infants.

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

50 people

The number who actually took part.

Started

Apr 2022

Finished

Jan 2025

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

Infant born very premature and aged less than 8 days ventilated and sedated in neonatal reanimation

Ages

0 to 7 days

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: * Infant born very premature before 34 weeks of amenorrhoea + 0 day * Age ≤ 7 days * Admitted in neonatal reanimation * Sedated, intubated, ventilated Exclusion Criteria: * High frequency oscillation ventilation * Heart rate non sinusal * Inotropes and atropine * Opposition from the guardian of parental authority * Difficulty of comprehension or communication making the parental information impossible

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As listed by the trial registrant

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

Neonatal Pain measurement Reanimation

Contacts and locations

Locations

  • Hop Jeanne de Flandre Chu Lille

    Lille, 59037, France

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