Magnetic Resonance ImagingBEBEDOLNCT05170178
Cracking the Code of Crying Babies: How Familiarity Changes the Interpretation of Cries
A study testing inclusion and familiarization and fMRI acquisition and closure in people with Magnetic Resonance Imaging and Neuronal Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Neuronal Activity
- What is being tested?
- inclusion and familiarization and fMRI acquisition and closure
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jun 2022to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 :
Show all 12Show fewer
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Magnetic Resonance Imaging, Neuronal Activity
- Being tested
- inclusion and familiarization, fMRI acquisition and closure
- Keywords
- baby cries, pain, brain responses, fmRI, familiarity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclusion and familiarizationBehavioural
- 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 closureBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Women with parental experience caring for infants | Experimental | Women parent of a child under 2 years old Receives: Behavioral: inclusion and familiarization; Behavioral: fMRI acquisition and closure |
| Men with parental experience caring for infants | Experimental | Men parent of a child under 2 years old Receives: Behavioral: inclusion and familiarization; Behavioral: fMRI acquisition and closure |
| Women with professional experience in caring for infants | Experimental | Women in daily contact with infants in professional circle (e.g., nannies, pediatricians, midwives, maternity nurses) without dependent children under 2 years old Receives: Behavioral: inclusion and familiarization; Behavioral: fMRI acquisition and closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the whole listening session
Secondary outcomes (2)
participants'experience at caring for babies
Experience at caring for babies : Yes or No
Measured: At the inclusion visit
participants' sex
Sex : Male or female
Measured: At the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start30 Jun 2022
- Primary completion26 Apr 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group with parental experience caring for infants (20 men and 20 women) Group with professional experience in caring for infants (20 women)
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland PEYRON, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170178
- Sponsor's protocol ID
- 21CH161
- Other IDs
- ANSM
- Acronym
- BEBEDOL
- Status last verified
- Jun 2023
- First submitted
- 22 Dec 2021
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cracking the Code of Crying Babies: How Familiarity Changes the Interpretation of Cries
- ClinicalTrials.gov ID
- NCT05170178
- Acronym / sponsor ID
- BEBEDOL / 21CH161
- Conditions
- Magnetic Resonance Imaging, Neuronal Activity
- Keywords
- baby cries, pain, brain responses, fmRI, familiarity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group with parental experience caring for infants (20 men and 20 women) Group with professional experience in caring for infants (20 women)
| Arm | Type | Receives |
|---|---|---|
| Women with parental experience caring for infants | Experimental | Behavioral: inclusion and familiarization, Behavioral: fMRI acquisition and closureWomen parent of a child under 2 years old |
| Men with parental experience caring for infants | Experimental | Behavioral: inclusion and familiarization, Behavioral: fMRI acquisition and closureMen parent of a child under 2 years old |
| Women with professional experience in caring for infants | Experimental | Behavioral: inclusion and familiarization, Behavioral: fMRI acquisition and closureWomen in daily contact with infants in professional circle (e.g., nannies, pediatricians, midwives, maternity nurses) without dependent children under 2 years old |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
- Men or women between 18 and 50 years old
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Men with parental experience caring for infants, Women with parental experience caring for infants, Women with professional experience in caring for infants |
| 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 | Behavioural | Men with parental experience caring for infants, Women with parental experience caring for infants, Women with professional experience in caring for infants |
Primary outcome
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.
2 secondary outcomes
participants'experience at caring for babies
Time frame: At the inclusion visit
participants' sex
Time frame: At the inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland PEYRON, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inclusion and familiarization and fMRI acquisition and closure in people with Magnetic Resonance Imaging and Neuronal Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal (blood oxygen level-dependent) (time frame: during the whole listening session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.