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Completed

NCT Number: NCT05170178

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

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.

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Key information

Conditions

Magnetic Resonance Imaging Neurologic Manifestations Neuronal Activity Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HCL, Bron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inclusion and familiarization

Behavioral
  • 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

Behavioral
  • 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

Primary outcomes

  1. BOLD signal (blood oxygen level-dependent)

    Time frame: during the whole listening session

    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.

Secondary outcomes

  1. participants'experience at caring for babies

    Time frame: At the inclusion visit

    Experience at caring for babies : Yes or No

  2. participants' sex

    Time frame: At the inclusion visit

    Sex : Male or female

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: BEBEDOL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2021
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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