[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"excessive-crying\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:excessive-crying":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100646365","assessment-of-prolonged-pain-in-infants-with-excessive-crying-the-role-of-thermal-imaging-100646365",false,"NCT07693179","Assessment of Prolonged Pain in Infants With Excessive Crying: Contribution of Infrared Thermal Imaging - The NEOTHERM Pilot Study","NEOTHERM","Inclusion criteria:\n\n* Infants aged 2 to 6 weeks post-term in corrected age at the first assessment.\n* Born at or after 32 weeks' gestational age.\n* No known neurological or gastrointestinal disease.\n* Written informed consent from the holder(s) of parental authority.\n* Meeting the criteria for one of the following two cohorts:\n\n  * 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\u002For flexed legs.\n  * Typical-crying (TC) cohort: crying for less than 2 hours per day during the week preceding the assessment.\n\nInfants crying for 2 to 3 hours per day during the week preceding the assessment will not be included in either cohort.\n\nExclusion criteria:\n\n* Confirmed cerebral lesions identified by ultrasound or magnetic resonance imaging.\n* Major congenital or chromosomal abnormalities.\n* Growth faltering.\n* Birth before 32 weeks' gestational age.\n* Holder(s) of parental authority who do not speak French.\n* Lack of written informed consent from the holder(s) of parental authority.\n* Lack of affiliation with a French social security scheme.\n* Any situation falling under specific legal protection provisions under French law.",true,"ALL","2 Weeks","6 Weeks",{"count":21,"type":22},80,"ESTIMATED","OBSERVATIONAL","NEOTHERM is a multicenter, prospective, observational pilot study examining whether infrared thermal imaging (ITI) can contribute to the assessment of prolonged pain in infants with excessive crying. Thermal measurements of the face and body will be compared with scores obtained using the EDIN behavioral pain and discomfort scale. The study will also examine associations between ITI measures, EDIN scores, and hair cortisol concentrations as a biomarker of prolonged stress, and will describe early motor organization and psychomotor development using General Movements Assessment and Bayley-4. Eighty infants will be enrolled in two comparison groups based on daily crying duration and assessed longitudinally at two standardized visits. The main hypothesis is that ITI will identify cutaneous thermal changes associated with prolonged pain and that these measures will be associated with EDIN scores.",[26,27],"Excessive Crying","Prolonged Pain",[29,26,27,30,31,32,33,34,35,36,37],"Infant","Infrared Thermal Imaging","EDIN Scale","Hair Cortisol","General Movements Assessment","Early Neurodevelopment","Psychomotor Development","Chronic Stress","Multimodal Assessment","NOT_YET_RECRUITING","2026-08-31",{"date":41,"type":42},"2026-09-03","ACTUAL",{"date":44,"type":22},"2026-09",{"date":46,"type":22},"2028-07",{"name":48,"class":49},"Centre Hospitalier de Saint-Denis","OTHER",3]