Excessive CryingNEOTHERMNCT07693179
Assessment of Prolonged Pain in Infants With Excessive Crying: Contribution of Infrared Thermal Imaging - The NEOTHERM Pilot Study
An observational study of Excessive Crying and Prolonged Pain, run by Centre Hospitalier de Saint-Denis at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Excessive Crying, Prolonged Pain
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Centre Médico-Psychologique Périnatalité et Petite Enfance Brantôme
Paris, Île-de-France Region, 75003
Anne-Sylvie PELLOUX, Doctor, +33 01 48 04 85 56, cmp-brantome.75i01@ght94n.fr
Centre Hospitalier de Saint-Denis - Department of Neonatology
Saint-Denis, Île-de-France Region, 93200
Alizée LORI, Doctor, +33 01 42 35 61 40, alizee.lori@ch-stdenis.fr
Centre Hospitalier de Saint-Denis - Department of Perinatal Psychiatry
Saint-Denis, Île-de-France Region, 93200
Laure QUANTIN, Doctor, +33 01 48 22 19 51, laure.quantin@ch-stdenis.fr
About this study
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.
- Conditions
- Excessive Crying, Prolonged Pain
- Keywords
- Infant, Excessive Crying, Prolonged Pain, Infrared Thermal Imaging, EDIN Scale, Hair Cortisol, General Movements Assessment, Early Neurodevelopment, Psychomotor Development, Chronic Stress, Multimodal Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (T1) and approximately 8 weeks after baseline (T2)
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (T1) through approximately 8 weeks after baseline (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive CryingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Pratique des Hautes Etudes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693179
- Sponsor's protocol ID
- 2025-A00767-42
- Acronym
- NEOTHERM
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prolonged Pain in Infants With Excessive Crying: Contribution of Infrared Thermal Imaging - The NEOTHERM Pilot Study
- ClinicalTrials.gov ID
- NCT07693179
- Acronym / sponsor ID
- NEOTHERM / 2025-A00767-42
- Conditions
- Excessive Crying, Prolonged Pain
- Keywords
- Infant, Excessive Crying, Prolonged Pain, Infrared Thermal Imaging, EDIN Scale, Hair Cortisol, General Movements Assessment, Early Neurodevelopment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Collaborators
- Ecole Pratique des Hautes Etudes
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Infrared Thermal Imaging Indices and EDIN Total Score
Time frame: 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.
4 secondary outcomes
Associations Between Hair Cortisol Concentration, Infrared Thermal Imaging Indices, and EDIN Total Score
Time frame: At baseline (T1) and approximately 8 weeks after baseline (T2)
General Movements Assessment Scores and Motor Patterns
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
Time frame: At baseline (T1) and approximately 8 weeks after baseline (T2)
Associations Between Early Motor Organization and Prolonged Pain or Stress Indicators
Time frame: From baseline (T1) through approximately 8 weeks after baseline (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Crying and Prolonged Pain, run by Centre Hospitalier de Saint-Denis at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joëlle Provasi, PhD (+33 1 88 12 02 99, joelle.provasi@ephe.psl.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.