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

31 agosto 2026 aggiornato da: Centre Hospitalier de Saint-Denis

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Joëlle Provasi, PhD
Numero di telefono: +33 1 88 12 02 99
Email: joelle.provasi@ephe.psl.eu

Backup dei contatti dello studio

Nome: Alizée LORI, MD
Numero di telefono: +33 01 42 35 61 40
Email: alizee.lori@ch-stdenis.fr

Luoghi di studio

Francia
- Île-de-France Region
  - Paris, Île-de-France Region, Francia, 75003
    - Centre Médico-Psychologique Périnatalité et Petite Enfance Brantôme
    - Contatto:
      
      Anne-Sylvie PELLOUX, Doctor
      
      Numero di telefono: +33 01 48 04 85 56
      
      Email: cmp-brantome.75i01@ght94n.fr
  - Saint-Denis, Île-de-France Region, Francia, 93200
    - Centre Hospitalier de Saint-Denis - Department of Neonatology
    - Contatto:
      
      Alizée LORI, Doctor
      
      Numero di telefono: +33 01 42 35 61 40
      
      Email: alizee.lori@ch-stdenis.fr
  - Saint-Denis, Île-de-France Region, Francia, 93200
    - Centre Hospitalier de Saint-Denis - Department of Perinatal Psychiatry
    - Contatto:
      
      Laure QUANTIN, Doctor
      
      Numero di telefono: +33 01 48 22 19 51
      
      Email: laure.quantin@ch-stdenis.fr

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Bambino

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Experimental group: excessive crying duration

The study population will comprise 80 infants recruited prospectively from three participating centers. Infants will be enrolled at 2 to 6 weeks post-term in corrected age and reassessed at 10 to 14 weeks post-term in corrected age.

Based on the 7-day parental crying diary completed before the first assessment, infants will be classified into two predefined cohorts: an excessive-crying (EC) cohort and a typical-crying (TC) cohort, with 40 infants planned in each cohort.

Participants in the TC cohort will be matched to participants in the EC cohort according to corrected age at assessment (±1 week), sex when possible, gestational age at birth (±1 week), feeding modality, and maternal parity.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
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.
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.

Gruppo / Coorte

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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Association Between Infrared Thermal Imaging Indices and EDIN Total Score Lasso di tempo: At baseline (T1) and approximately 8 weeks after baseline (T2)	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.	At baseline (T1) and approximately 8 weeks after baseline (T2)

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Associations Between Hair Cortisol Concentration, Infrared Thermal Imaging Indices, and EDIN Total Score Lasso di tempo: At baseline (T1) and approximately 8 weeks after baseline (T2)	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	At baseline (T1) and approximately 8 weeks after baseline (T2)
General Movements Assessment Scores and Motor Patterns Lasso di tempo: At baseline (T1); approximately 15, 30, and 45 days after baseline; and approximately 8 weeks after baseline (T2)	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.	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 Lasso di tempo: At baseline (T1) and approximately 8 weeks after baseline (T2)	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.	At baseline (T1) and approximately 8 weeks after baseline (T2)
Associations Between Early Motor Organization and Prolonged Pain or Stress Indicators Lasso di tempo: From baseline (T1) through approximately 8 weeks after baseline (T2)	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.	From baseline (T1) through approximately 8 weeks after baseline (T2)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre Hospitalier de Saint-Denis

Collaboratori

Ecole Pratique des Hautes Etudes

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 luglio 2028

Completamento dello studio (Stimato)

1 luglio 2028

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

2025-A00767-42

Informazioni su farmaci e dispositivi, documenti di studio

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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .