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

Study acronym: NEOTHERM
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Jul 2026 → Jul 2028
Primary endpoints removed 3 → 1 primary endpoints
See other at-risk trials from Centre Hospitalier de Saint-Denis

Record History

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  1. Primary completion pushed from Jul 2026 to Jul 2028v2 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 50 → 80 participants
    • Start date: Jul 2026 to Sep 2026
    • Trial sites expanded: 0 → 3 locations
    • Eligibility criteria expanded, about 98 words
    • Secondary endpoints: 1 to 4
    • Study title expanded, about 5 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07693179
Lead Sponsor Centre Hospitalier de Saint-Denis
Collaborators: Ecole Pratique des Hautes Etudes
Conditions
(from sponsor)		 Excessive Crying, Prolonged Pain
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov