Cracking the Code of Crying Babies: How Familiarity Changes the Interpretation of Cries
BEBEDOL
2 other identifiers
interventional
62
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2021
CompletedFirst Posted
Study publicly available on registry
December 27, 2021
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2023
CompletedAugust 4, 2023
June 1, 2023
10 months
December 22, 2021
August 3, 2023
Conditions
Keywords
Outcome Measures
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.
during the whole listening session
Secondary Outcomes (2)
participants'experience at caring for babies
At the inclusion visit
participants' sex
At the inclusion visit
Study Arms (3)
Women with parental experience caring for infants
EXPERIMENTALWomen parent of a child under 2 years old
Men with parental experience caring for infants
EXPERIMENTALMen parent of a child under 2 years old
Women with professional experience in caring for infants
EXPERIMENTALWomen in daily contact with infants in professional circle (e.g., nannies, pediatricians, midwives, maternity nurses) without dependent children under 2 years old
Interventions
* 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
* 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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
HCL
Bron, France
Chu Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland PEYRON, MD
Centre Hospitalier Universitaire de Saint Etienne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2021
First Posted
December 27, 2021
Study Start
June 30, 2022
Primary Completion
April 26, 2023
Study Completion
May 12, 2023
Last Updated
August 4, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share