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NOT YET RECRUITING
NCT07693179

Assessment of Prolonged Pain in Infants With Excessive Crying: Contribution of Infrared Thermal Imaging - The NEOTHERM Pilot Study

Sponsor: Centre Hospitalier de Saint-Denis

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

2 Weeks - 6 Weeks

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-09

Completion Date

2028-07

Last Updated

2026-09-03

Healthy Volunteers

Yes

Locations (3)

Centre Médico-Psychologique Périnatalité et Petite Enfance Brantôme

Paris, Île-de-France Region, France

Centre Hospitalier de Saint-Denis - Department of Neonatology

Saint-Denis, Île-de-France Region, France

Centre Hospitalier de Saint-Denis - Department of Perinatal Psychiatry

Saint-Denis, Île-de-France Region, France