Heat-Sensing cameras could reveal hidden pain in crying babies
NCT ID NCT07693179
First seen Jul 09, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This pilot study investigates whether thermal imaging can identify chronic pain in infants aged 3 to 9 weeks who cry excessively. Researchers will compare body and face temperature patterns with a standard behavioral pain scale and a stress hormone (cortisol) from hair samples. The goal is to find a non-invasive, objective way to assess pain in babies who cannot communicate verbally.
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 provide a non-invasive, objective way to assess pain in infants who cannot speak, improving diagnosis and treatment.
- What could go wrong
- This is a small pilot study, so results may not be conclusive or generalizable. Thermal imaging may not reliably distinguish pain from other causes of crying.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
Experimental group: excessive crying duration The study population will comprise 80 infants recruited prospectively from three participating centers. Infants will be enrolled at 2 to 6 weeks post-term in corrected age and reassessed at 10 to 14 weeks post-term in corrected age. Based on the 7-day parental crying diary completed before the first assessment, infants will be classified into two predefined cohorts: an excessive-crying (EC) cohort and a typical-crying (TC) cohort, with 40 infants planned in each cohort. Participants in the TC cohort will be matched to participants in the EC cohort according to corrected age at assessment (±1 week), sex when possible, gestational age at birth (±1 week), feeding modality, and maternal parity.
- Ages
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2 to 6 weeks
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Infants aged 2 to 6 weeks post-term in corrected age at the first assessment. * Born at or after 32 weeks' gestational age. * No known neurological or gastrointestinal disease. * Written informed consent from the holder(s) of parental authority. * Meeting the criteria for one of the following two cohorts: * Excessive-crying (EC) cohort: crying for more than 3 hours per day on at least 3 consecutive days during the 7 days preceding the assessment (modified Wessel criteria), together with at least two of the following three protocol-specified Rome IV-related features: crying without an apparent cause, inconsolable crying, and associated signs including agitation, facial flushing, clenched fists, and/or flexed legs. * Typical-crying (TC) cohort: crying for less than 2 hours per day during the week preceding the assessment. Infants crying for 2 to 3 hours per day during the week preceding the assessment will not be included in either cohort. Exclusion criteria: * Confirmed cerebral lesions identified by ultrasound or magnetic resonance imaging. * Major congenital or chromosomal abnormalities. * Growth faltering. * Birth before 32 weeks' gestational age. * Holder(s) of parental authority who do not speak French. * Lack of written informed consent from the holder(s) of parental authority. * Lack of affiliation with a French social security scheme. * Any situation falling under specific legal protection provisions under French law.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre Hospitalier de Saint-Denis - Department of Neonatology
Saint-Denis, Île-de-France Region, 93200, France
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Centre Hospitalier de Saint-Denis - Department of Perinatal Psychiatry
Saint-Denis, Île-de-France Region, 93200, France
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Centre Médico-Psychologique Périnatalité et Petite Enfance Brantôme
Paris, Île-de-France Region, 75003, France
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