Assessment of Prolonged Pain in Infants With Excessive Crying: the Role of Thermal Imaging

Sponsor
Centre Hospitalier de Saint-Denis
Study ID
NCT07693179
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain
  • Crying

Eligibility Criteria

Sex
ALL
Age
3 Weeks - 9 Weeks
Healthy Volunteers
Accepted

Study Details

This study aims to propose a clinical assessment of chronic pain in infants using thermal imaging, by comparing the results of a validated behavioral scale (the EDIN) and a stress biomarker (salivary cortisol levels) with systematic thermal images of the body and face.

Key Dates

First listed
Jul 9, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Experimental group: excessive crying time
    Infants between 3 and 9 weeks post-term (SPT) in corrected age who meet the ROME IV criteria for infant colic, with crying episodes lasting \> 3 hours per day for more than 3 days during the week prior to evaluation (modified Weissel criteria). No known neurological or gastrointestinal disorders. Consent from legal guardians.
  • Arm: Control group: physiological crying duration
    Infants between 3 and 9 weeks post-term (SPT) in corrected age, whose daily crying time was less than 2 hours per day during the week preceding the evaluation. No known neurological or gastrointestinal disorders. Consent from legal guardians.

Primary Outcome Measure

Chronic pain in infants assessed using the EDIN scale: Neonatal Pain and Discomfort Scale [ Time Frame: 2 month ]

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