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

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.

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging; Neuronal Activity
• Intervention / Treatment: Behavioral: inclusion and familiarization; Behavioral: fMRI acquisition and closure

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • HCL
  • Saint-etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women with parental experience caring for infants; Women parent of a child under 2 years old	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; Behavioral: 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
Experimental: Men with parental experience caring for infants; Men parent of a child under 2 years old	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; Behavioral: 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
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; 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; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
participants'experience at caring for babies	Experience at caring for babies : Yes or No	At the inclusion visit
participants' sex	Sex : Male or female	At the inclusion visit

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Roland PEYRON, MD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: pain; baby cries; brain responses; fmRI; familiarity
• Other Study ID Numbers: 21CH161; ANSM (Other Identifier: 2025-A02220-49)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No