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

Sponsor
Centre Hospitalier de Saint-Denis
Study ID
NCT07693179
Status
Not Yet Recruiting

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Conditions

  • Excessive Crying
  • Prolonged Pain

Eligibility Criteria

Sex
ALL
Age
2 Weeks - 6 Weeks
Healthy Volunteers
Accepted

Study Details

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 Dates

First listed
Jul 9, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Excessive-Crying (EC) Cohort
    Infants aged 2 to 6 weeks post-term (corrected age) at the first assessment, with crying lasting more than 3 hours per day on at least 3 consecutive days during the 7 days preceding the assessment (modified Wessel criteria). Infants must also meet at least two of the following three protocol-specified Rome IV-related features: crying without an apparent cause, inconsolable crying, and associated signs including agitation, facial flushing, clenched fists, and/or flexed legs. No intervention will be assigned. Participants will undergo the observational assessments specified in the study protocol.
  • Arm: Typical-Crying (TC) Cohort
    Infants aged 2 to 6 weeks post-term (corrected age) at the first assessment, with crying lasting less than 2 hours per day during the 7 days preceding the assessment. Participants in the TC cohort will be matched to participants in the EC cohort according to corrected age at assessment (±1 week), sex where possible, gestational age at birth (±1 week), feeding modality, and maternal parity. No intervention will be assigned. Participants will undergo the observational assessments specified in the study protocol.

Primary Outcome Measure

Association Between Infrared Thermal Imaging Indices and EDIN Total Score [ Time Frame: At baseline (T1) and approximately 8 weeks after baseline (T2) ]

Central Contacts