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Can we finally measure pain in babies? new study aims to find out

NCT ID NCT06164028

Knowledge-focused Sponsor: Duke 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study involves interviews with 60 caregivers and clinicians to see how well they can describe and report acute pain in infants and young children under 2 years old. The goal is to create reliable tools for measuring pain in future clinical trials. The study does not test any treatment or medication.

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 better tools for measuring pain in babies, helping future studies develop more effective pain treatments for young children.
What could go wrong
This is a small, early-stage interview study, not a treatment trial. The findings may not translate into widely usable assessments or directly improve patient care.

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 60 people

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

Started

Aug 2023

Expected to finish

Aug 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.

Who is studied

Caregivers who cares for a child who is between 0 and 2 years and experiencing or has experienced acute pain. Clinicians who treats or works with pediatric patients who are between 0 and 2 years and being treated for acute pain.

Ages

18 years and older

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: Caregivers * Cares for a child who is both: Between 0 and \<2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: Malignant or non-malignant visceral or hematologic disease; Surgery (or other procedure); Trauma or injury ; Congenital conditions * Is over the age of 18 years * Can speak and understand English or Spanish * Is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record. Clinicians * Practicing clinician in a clinical care environment * Treats or works with pediatric patients who are between 0 and \<2 years of age AND being treated for acute pain. * Cares for pediatric patients \>50% of their clinical time. * Holds one of the following titles/positions: physician, clinical pharmacist (Pharm D), nurse practitioner, physician's assistant, nurse (with a BSN/RN or higher) * Is over the age of 18 years * Can speak and understand English * Is capable of and willing to provide informed consent for interview participation. Exclusion Criteria: * Lack of access to a telephone or computer for interview * For caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.

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Conditions

The condition(s) this trial relates to.

Acute Pain

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

    1 site. 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

  • Duke Clinical Research Institute

    RECRUITING

    Durham, North Carolina, 27701, United States

More trials for these conditions

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