NewbornBABIES_CRYNCT01732978
Are Parents Privileged Listeners Their Baby ?
A study testing Crying record in people with Newborn, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state. The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on… Read more about this study
- Who is it for?
- Ages Up to 1 weekHealthy volunteers can take part
- Conditions the study is for
- Newborn
- What is being tested?
- Crying record
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Dec 2014
- 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 Up to 1 week
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- born in the University Hospital of Saint Etienne (inborn) whatever its term birth
Who cannot join
- Congenital oropharyngeal tract preventing vocalization physiological newborn
Trial locations and contacts
1 site in 1 country.
About this study
The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state.
The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on parental response.
Read more
The detailed study of the acoustic structure of crying and analysis of parental perception will determine the dynamics during the first weeks of life of this recognition, and the influence of factors such as parental presence, or breastfeeding .
For this study is organized in three stages: first, the recording of the baby's crying Secondly, a listening test parental soundtracks and third analysis of the acoustic structure of crying and parental response.
- Conditions
- Newborn
- Being tested
- Crying record
- Keywords
- Crying record, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crying recordBehavioural
Recording spontaneous crying is as soon as possible after birth. Crying is recorded twice during the first week of life.
Listening tests:
Tests will be conducted playbacks with the father and mother separately, and with a staff
| Study group | Role | What they receive |
|---|---|---|
| Babies | Other | Any child born in the University Hospital of Saint Etienne (inborn) whatever its term birth, hospitalized in a neonatal unit at the time of registration (after 37 weeks of gestation for preterm infants) or maternity Receives: Behavioral: Crying record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crying recorded
The acoustic structure of crying recorded the first days of life will be analyzed and aims to characterize an individual signature and the dynamic function of time of this structure.
Measured: Second day of life of the parent's child
Secondary outcomes (1)
Biological correlation
The acoustic structure of crying will also be studied to establish a possible correlation with biological parameters baby
Measured: Second day of life of parents' child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MATHEVON, PhD, Study chair, Jean Monnet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732978
- Sponsor's protocol ID
- 1208093
- Acronym
- BABIES_CRY
- Status last verified
- Oct 2018
- First submitted
- 20 Nov 2012
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Parents Privileged Listeners Their Baby ?
- ClinicalTrials.gov ID
- NCT01732978
- Acronym / sponsor ID
- BABIES_CRY / 1208093
- Conditions
- Newborn
- Keywords
- Crying record, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Nov 2012 (estimated)
- 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.
The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state.
The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on parental response.
The detailed study of the acoustic structure of crying and analysis of parental perception will determine the dynamics during the first weeks of life of this recognition, and the influence of factors such as parental presence, or breastfeeding .
For this study is organized in three stages: first, the recording of the baby's crying Secondly, a listening test parental soundtracks and third analysis of the acoustic structure of crying and parental response.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babies | Other | Behavioral: Crying recordAny child born in the University Hospital of Saint Etienne (inborn) whatever its term birth, hospitalized in a neonatal unit at the time of registration (after 37 weeks of gestation for preterm infants) or maternity |
Who may qualify
- Ages
- Up to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- born in the University Hospital of Saint Etienne (inborn) whatever its term birth
Key exclusion criteria (1 listed)
- Congenital oropharyngeal tract preventing vocalization physiological newborn
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 |
|---|---|---|
| Crying recordRecording spontaneous crying is as soon as possible after birth. Crying is recorded twice during the first week of life. Listening tests: Tests will be conducted playbacks with the father and mother separately, and with a staff | Behavioural | Babies |
Primary outcome
Crying recorded
Time frame: Second day of life of the parent's child
The acoustic structure of crying recorded the first days of life will be analyzed and aims to characterize an individual signature and the dynamic function of time of this structure.
1 secondary outcome
Biological correlation
Time frame: Second day of life of parents' child
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 24 Oct 2018.
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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.
Nicolas MATHEVON, PhD study chair
Jean Monnet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crying record in people with Newborn, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site 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 1 inclusion and 1 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 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Crying recorded (time frame: Second day of life of the parent's child). 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 24 Oct 2018.