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