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Machine learning and cuddles: a new approach to pain in premature infants

NCT ID NCT05579496

Knowledge-focused Sponsor: York University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study aims to improve how pain is assessed and managed in premature babies in the neonatal intensive care unit (NICU). Researchers are using machine learning to analyze video, brain activity, heart rate, and breathing patterns to better distinguish between painful and non-painful distress. They are also studying how skin-to-skin contact with a parent can help reduce pain responses. The study involves 400 preterm infants and their parents, observing them during routine heel lances.

What this could mean

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

Active substance
skin-to-skin contact
What this could lead to
If successful, this could lead to better pain detection and more effective non-drug pain relief for premature babies in intensive care.
What could go wrong
This is an observational study, so it won't directly test a treatment. The machine learning algorithm may not work as well in real-world settings, and results may not apply to all 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

About 400 people

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

Started

Nov 2020

Expected to finish

Mar 2031

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

Preterm infants

Ages

25 to 33 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.

QUALITATIVE INTERVIEWS Inclusion Criteria: * Parents of a child currently in the NICU or * Health professionals currently working in the NICU. Exclusion Criteria: \*Participants who cannot communicate fluently in English QUANTITITATIVE DATA CAPTURE (video, eeg, ecg, RR, SPo2) Inclusion Criteria: * Infants born between 25 0/7 weeks 32 6/7 weeks gestational age * Infants who are within 8 weeks postnatal age * Infants who are undergoing a routine heel lance Exclusion Criteria: * Infants with congenital malformations * Infants receiving analgesics or sedatives at the time of study (aside from sucrose) * Infants with history of perinatal hypoxia/ischemia at the time of study * Infants with diaper rash or excoriated buttocks * Parents who are not fluent in English

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Conditions

The condition(s) this trial relates to.

Acute Pain agnosia

As listed by the trial registrant

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

Acute pain

How to take part

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

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  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

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

  • University College London Hospital

    RECRUITING

    London, No Province, N1 2EP, United Kingdom

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