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Not yet recruiting NCT07693179

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

— Observational Chronic Pain Crying

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Pain, Crying. Basic parameters: 3 Weeks — 9 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessment of Prolonged Pain in Infants With Excessive Crying: the Role of Thermal Imaging - A Pilot Study

Overview

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.

Primary outcome measures

  • Chronic pain in infants assessed using the EDIN scale: Neonatal Pain and Discomfort Scale [Time frame: 2 month]
  • Chronic Pain in Infants Assessed Using Capillary Cortisol Levels (hair samples weighing less than 2.5 mg) [Time frame: 2 month]
  • Assessment of Chronic Pain in Infants Using Infrared Thermography [Time frame: 2 month]
Secondary outcome measures (1)
  • Chronic pain in infants assessed using general motor skill analyses based on the Bayley Scale-4th edition [Time frame: 2 month]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07693179 · 0092_EPHE_NEOTHERM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗