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CompletedNCT05170178BEBEDOLUpdated Aug 4, 2023

Cracking the Code of Crying Babies: How Familiarity Changes the Interpretation of Cries

An interventional study of inclusion and familiarization and fMRI acquisition and closure in Magnetic Resonance Imaging and Neuronal Activity, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 2 sites in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Understanding babies' signals is essential to meet their needs. Recent works suggest that crying provides useful information, not only allowing parents to recognize their baby among others (static information), but also to distinguish between mild discomfort and pain cries (dynamic information). The perception of this information by adults involves a "parental" brain network including brain areas involved in empathy, attention, emotional regulation, motor as well as regions of the limbic system or associated with the reward network.

Read the detailed description

This network is involved when listening to cries of familiar babies, or pain cries. How do we become specialist of a baby's cries? To date, no functional imaging study has examined the specific brain activations when listening to the cries of a familiar baby in different situations, particularly painful ones.

02

Conditions studied

  • Magnetic Resonance Imaging
  • Neuronal Activity

Keywords

  • baby cries
  • pain
  • brain responses
  • fmRI
  • familiarity
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

For all volunteers:

  • Affiliated or entitled to a social security plan
  • Right-handed by the Edinburgh laterality test
  • Having given free, informed and written consent to participate in the study
  • Having given their consent for the communication of the MRI results to their attending physician

Group with parental experience caring for infants :

  • Men or women between 18 and 50 years old
  • Parent of a child under 2 years old

Group with professional experience in caring for infants

  • Women between 18 and 50 years old
  • Without dependent children under 2 years of age
  • People in daily contact with infants in the professional circle (e.g. nurses, pediatricians, midwives, maternity nurses, etc)

Exclusion criteria

Exclusion Criteria

  • Pregnant women, parturient, nursing mothers or parents
  • Persons deprived of liberty, hospitalized without consent, hospitalized for purposes other than research
  • Minors
  • Adults under legal protection (guardianship) or unable to express their consent
  • Subjects with contraindications to the MRI examination: use of a pacemaker or an insulin pump, wearing a metallic prothesis, an intracerebral clip or a piercing, claustrophobia,
  • Taking medication for less than 12 hours,
  • Neurological, psychiatric or auditory history or deficits.
  • Anxiety and/or depressive disorders
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Women with parental experience caring for infants

    Women parent of a child under 2 years old

    Behavioral: inclusion and familiarization · Behavioral: fMRI acquisition and closure

  • Experimental
    Men with parental experience caring for infants

    Men parent of a child under 2 years old

    Behavioral: inclusion and familiarization · Behavioral: fMRI acquisition and closure

  • Experimental
    Women with professional experience in caring for infants

    Women in daily contact with infants in professional circle (e.g., nannies, pediatricians, midwives, maternity nurses) without dependent children under 2 years old

    Behavioral: inclusion and familiarization · Behavioral: fMRI acquisition and closure

Interventions

  • Behavioralinclusion and familiarization

    * presentation of the study purpose and the protocol to the volunteer * clinical examination to check inclusion and exclusion criteria * Familiarization with the crying of one assigned baby, by listening to several bath cries from this baby

  • BehavioralfMRI acquisition and closure

    * Second phase of familiarization, listening again to bath cries of "their" assigned baby. These cries will be different from those listened during the first familiarization phase. * MRI acquisition: after acquisition of the anatomical images (5 min), the subjects will listen to 64 cries divided into 4 functional MRI sessions of 10 minutes each. The cries will be those of "their" baby or of unknown babies, evoked in a painful (vaccination) or a non-painful (bath) situation, presented in a pseudo-random order. Participants will be asked to assess whether they recognize "their" baby (yes/no) and whether they recognize a pain cry (yes/no). * debriefing * Protocol ending

06

What researchers measure

Primary outcomes

  1. BOLD signal (blood oxygen level-dependent)

    Measurement of the BOLD signal by fMRI (functional magnetic resonance imaging) in adults during listening to natural cries of a familiar baby and unknown babies, in two painful (vaccination) or non-painful (bath) situations.

    Time frame: during the whole listening session

Secondary outcomes

  1. participants'experience at caring for babies

    Experience at caring for babies : Yes or No

    Time frame: At the inclusion visit

  2. participants' sex

    Sex : Male or female

    Time frame: At the inclusion visit

07

Study locations

2 sites
  • HCL
    Bron, France
  • Chu Saint-Etienne
    Saint-etienne, 42055, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05170178
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Dec 27, 2021
Start date
Jun 30, 2022
Primary completion
Apr 26, 2023
Completion
May 12, 2023
Last update
Aug 4, 2023

Study contacts

Roland PEYRON, MD
principal investigator · Centre Hospitalier Universitaire de Saint Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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