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

N/ANot Yet RecruitingNCT07693179

Centre Hospitalier de Saint-Denis80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Excessive Crying Prolonged Pain

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 6 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Infants aged 2 to 6 weeks post-term in corrected age at the first assessment. * Born at or after 32 weeks' gestational age. * No known neurological or gastrointestinal disease. * Written informed consent from the holder(s) of parental authority. * Meeting the criteria for one of the following two cohorts: * Excessive-crying (EC) cohort: crying for more than 3 hours per day on at least 3 consecutive days during the 7 days preceding the assessment (modified Wessel criteria), together with 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. * Typical-crying (TC) cohort: crying for less than 2 hours per day during the week preceding the assessment. Infants crying for 2 to 3 hours per day during the week preceding the assessment will not be included in either cohort. Exclusion criteria: * Confirmed cerebral lesions identified by ultrasound or magnetic resonance imaging. * Major congenital or chromosomal abnormalities. * Growth faltering. * Birth before 32 weeks' gestational age. * Holder(s) of parental authority who do not speak French. * Lack of written informed consent from the holder(s) of parental authority. * Lack of affiliation with a French social security scheme. * Any situation falling under specific legal protection provisions under French law.

Outcomes

Primary Outcomes

Association Between Infrared Thermal Imaging Indices and EDIN Total Score

Mean skin temperatures will be extracted from predefined body and facial regions of interest. Infrared thermal imaging indices will include absolute bilateral body temperature differences, central-to-peripheral temperature gradients, and intra-facial temperature gradients calculated relative to the forehead. An absolute temperature difference greater than 0.5°C will be considered an abnormal thermal asymmetry. The EDIN is a behavioral scale assessing facial expression, body movements, sleep, interaction, and consolability. Each item is scored from 0 to 3. Higher scores indicate greater pain- or discomfort-related behaviors; a total score of 5 or higher indicates probable prolonged pain. Concordance between infrared thermal imaging indices and EDIN total scores will be quantified using Spearman rank correlation coefficients at each assessment. Thermal images will be analyzed by an external assessor blinded to the EDIN score and cohort classification.

Time frame: At baseline (T1) and approximately 8 weeks after baseline (T2)

Secondary Outcomes

Associations Between Hair Cortisol Concentration, Infrared Thermal Imaging Indices, and EDIN Total Score

Hair cortisol concentration will be measured in pg/mg of hair from a small sample collected from the occipital region. Cortisol will be quantified using high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Hair cortisol concentration will be investigated as a biomarker of prolonged stress. Spearman correlation coefficients will be calculated between hair cortisol concentration, infrared thermal imaging indices, and EDIN total scores

Time frame: At baseline (T1) and approximately 8 weeks after baseline (T2)

General Movements Assessment Scores and Motor Patterns

Spontaneous general movements will be recorded with the infant lying supine, wearing only a diaper or onesie, during 2 to 5 minutes of active wakefulness without crying, interaction, a pacifier, or hiccups. Recordings will be independently evaluated by two assessors trained in General Movements Assessment and blinded to cohort classification, EDIN scores, and infrared thermal imaging results. The General Movement Optimality Score-Revised (GMOS-R; maximum score 38) will be used at Visit 1. The Motor Optimality Score- Revised (MOS-R) will be used at Visit 2; scores of 25 to 28 are considered optimal, whereas lower scores indicate less optimal motor organization. Qualitative motor characteristics, including movement quality, variability, fluency, symmetry, posture, and atypical movement patterns, will also be described and compared between cohorts.

Time frame: At baseline (T1); approximately 15, 30, and 45 days after baseline; and approximately 8 weeks after baseline (T2)

Psychomotor Development Assessed Using the Bayley Scales of Infant and Toddler Development, Fourth Edition

Psychomotor development will be assessed using the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4). Five subtests will be administered: cognitive development, receptive communication, expressive communication, fine motor development, and gross motor development. Raw subtest scores will be converted to scalar and composite scores using the normative tables of the Bayley-4. Higher scores indicate better performance in the assessed developmental domain. Scores will be compared between the EC and TC cohorts. Scoring will be performed by an assessor blinded to cohort classification.

Time frame: At baseline (T1) and approximately 8 weeks after baseline (T2)

Associations Between Early Motor Organization and Prolonged Pain or Stress Indicators

Associations between General Movements characteristics, GMOS-R or MOS scores, Bayley-4 scores, infrared thermal imaging indices, EDIN total scores, and hair cortisol concentrations will be examined using Spearman correlations and exploratory regression analyses.

Time frame: From baseline (T1) through approximately 8 weeks after baseline (T2)

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

Overview

Conditions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts