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Assessment of Prolonged Pain in Infants With Excessive Crying: Contribution of Infrared Thermal Imaging - The NEOTHERM Pilot Study
Sponsor: Centre Hospitalier de Saint-Denis
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
Conditions
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