Assessment of Prolonged Pain in Infants With Excessive Crying: the Role of Thermal Imaging

NCT07693179 | Not Yet Recruiting

• 1 other identifier: 0092_EPHE_NEOTHERM
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Crying; Chronic Pain

Keywords

Infant; Chronic Pain; crying

Outcome Measures

Primary Outcomes (3)

• Chronic pain in infants assessed using the EDIN scale: Neonatal Pain and Discomfort Scale

  The EDIN is a validated behavioral scale for the heteroassessment of pain in newborns and infants up to 9 months of age. The EDIN scale includes 5 assessment criteria: facial expression, movements, sleep, interactive behavior, and comfort. Each item is scored on a 3-point scale based on symptom intensity; a score of 5 or higher indicates probable pain, and analgesia is recommended. It is easy to use, quick to administer (about 3 minutes), reliable (0.69), has good internal validity (0.92), and has the advantage of assessing prolonged pain.

  2 month

• Chronic Pain in Infants Assessed Using Capillary Cortisol Levels (hair samples weighing less than 2.5 mg)

  Cortisol is a steroid hormone involved in the stress response. Capillary cortisol levels have been studied in newborns as a biomarker of chronic stress and are associated with chronic pain in adults. Capillary hair sampling is a noninvasive and rapid method; the samples are easy to store and remain stable over time. Protocols have been validated for the collection and analysis of capillary cortisol levels in preterm infants using hair samples weighing less than 2.5 mg. Translated with DeepL.com (free version)

  2 month

• Assessment of Chronic Pain in Infants Using Infrared Thermography

  Full-body and facial thermographic images will be divided into regions of interest based on their vascular distribution. Asymmetries in body and facial temperatures will be systematically assessed. The child will be filmed in the supine position and then in the prone position, lying on their back, for 2 minutes on each side. Measurements will be taken using an OPTRIS 450 PI thermal camera. The images will then be analyzed by a specialized engineer who is blinded to the assignment group. Skin temperature regulation is central to the body's thermoregulation and is symmetrical and instantaneous under normal physiological conditions. Asymmetrical qualitative and quantitative changes in temperature indicate a metabolic, hemodynamic, or neurological alteration in thermoregulation in the affected region.

  2 month

Secondary Outcomes (1)

• Chronic pain in infants assessed using general motor skill analyses based on the Bayley Scale-4th edition

  2 month

Study Arms (2)

Experimental group: excessive crying time

Infants between 3 and 9 weeks post-term (SPT) in corrected age who meet the ROME IV criteria for infant colic, with crying episodes lasting \> 3 hours per day for more than 3 days during the week prior to evaluation (modified Weissel criteria). No known neurological or gastrointestinal disorders. Consent from legal guardians.

Control group: physiological crying duration

Infants between 3 and 9 weeks post-term (SPT) in corrected age, whose daily crying time was less than 2 hours per day during the week preceding the evaluation. No known neurological or gastrointestinal disorders. Consent from legal guardians.

Eligibility Criteria

• Age: 3 Weeks - 9 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Experimental group: excessive crying duration Infants between 3 and 9 weeks post-term (SPT) in corrected age, meeting the ROME IV criteria for infant colic, with a crying duration of \> 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. Control group: physiological crying duration Infants between 3 and 9 weeks post-term (SPT) in corrected age, whose daily crying time was less than 2 hours per day during the week prior to the evaluation. No known neurological or gastrointestinal pathology. Consent from legal guardians.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead
• Ecole Pratique des Hautes Etudes: collaborator

MeSH Terms

Conditions

Chronic Pain; Crying

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07