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Not Yet Recruiting NCT07693179

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

Conditions: Chronic Pain, Crying

Sex: All
Ages: 3 Weeks – 9 Weeks
Healthy volunteers: Yes
Enrollment: 50
Sponsor: Centre Hospitalier de Saint-Denis

Summary

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.

Eligibility Criteria

Inclusion criteria: * Infants between 3 and 9 weeks post-term (SPT) in corrected age. * Meeting the ROME IV criteria for infant colic. * With crying episodes lasting \> 3 hours per day for more than 3 days during the week preceding the evaluation (modified Weissel criteria). * No known neurological or gastrointestinal pathology. * Consent from legal guardians. * Infants between 3 and 9 weeks post-term (SPT) in corrected age whose daily crying is less than 2 hours per day * Consent from legal guardians. Exclusion criteria: * Confirmed brain lesions (ultrasound/MRI). * Major congenital or chromosomal abnormalities. * Stunted growth and weight gain. * Born before 37 weeks' gestational age. * Legal guardians who do not speak French. * Lack of consent from legal guardians.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07693179). StuddyBuddy aggregates publicly available trial information.