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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Neuronal Activity
Magnetic Resonance Imaging

Treatments

Behavioral: inclusion and familiarization
Behavioral: fMRI acquisition and closure

Study type

Interventional

Funder types

Other

Identifiers

NCT05170178
ANSM (Other Identifier)
21CH161

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 3 patient groups

Women with parental experience caring for infants
Experimental group
Description:
Women parent of a child under 2 years old
Treatment:
Behavioral: inclusion and familiarization
Behavioral: fMRI acquisition and closure
Men with parental experience caring for infants
Experimental group
Description:
Men parent of a child under 2 years old
Treatment:
Behavioral: inclusion and familiarization
Behavioral: fMRI acquisition and closure
Women with professional experience in caring for infants
Experimental group
Description:
Women in daily contact with infants in professional circle (e.g., nannies, pediatricians, midwives, maternity nurses) without dependent children under 2 years old
Treatment:
Behavioral: inclusion and familiarization
Behavioral: fMRI acquisition and closure

Trial contacts and locations

2

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Central trial contact

Roland PEYRON, MD; Hélène RAINGARD, CRA

Data sourced from clinicaltrials.gov

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