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

Magnetic Resonance Imaging Clinical Trial

— BEBEDOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170178
• Other study ID #: 21CH161
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: May 12, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 12, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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
• 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

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Neuronal Activity

Intervention

Behavioral:
• inclusion 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
• fMRI 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

Locations

Country	Name	City	State
France	HCL	Bron
France	Chu Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	during the whole listening session
Secondary	participants'experience at caring for babies	Experience at caring for babies : Yes or No	At the inclusion visit
Secondary	participants' sex	Sex : Male or female	At the inclusion visit