InfantsLongCRYNCT03716882
Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification
An observational study of Infants, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Read more about this study
- Who is it for?
- Ages 1 day to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Infants
- What is being tested?
- Song Meter (SM)4
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 6 Jan 2020
- Phase
- Observational
- 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 1 day to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants at the birth
Who may be able to join
- any safe term infants (> 37SA)
- eutrophic and in good health
- infants sleeping in bed with bars without baby nest
- form signed by the holder of parental authority.
- Parents affiliated to a social security scheme
- Parents who to live in cities of Saint-Etienne, Villars, Saint Priest-en-Jarez, Etrat and Saint Jean-Bonnefonds, France
Who cannot join
- inter-uterine growth restriction
- antenatal neurological pathologies or at birth
- perinatal asphyxial encephalopathy
- antenatal pathologies (e.g. trisomy 21, hydrocephalus...)
- multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.
The cry phenomenon consists of complex acoustic signals produced by the vocal cords and filtered by the vocal tract. The vibrations frequency determines the fundamental frequency, itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a cry is modified during the passage through the upper airways forming broad bands called "resonance frequency" or "formants".
Read more
From the specificity of a crying sequence, it is possible to extract dynamic information and relate it to the perception that the adult has of it. Thus dynamic crying is often perceived by the adult as an imminent need of the baby.
Some studies have shown that a child's crying may change according to his degree of discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could vary along a continuum. These changes would explain why adult listeners would be able to dissociate crying babies of different intensities.
Conversely, an inappropriate response to crying could gradually generate disorders of the relationship between the baby and the parent.
However, despite their potential neuro-ethological interest, knowledge of information transmitted by babies's cry remains superficial. This could be related to the relatively obsolete techniques of recording or due to the lack of objective physiological data on babies 'cry. Finally, the perception and reactions of adults when they hear crying babies are not fully understood.
Read the detailed description
The objective of this study is to evaluate acoustic structures crying of infants from 1 to 4 months for to study individual acoustic signature.
- Conditions
- Infants
- Being tested
- Song Meter (SM)4
- Keywords
- Infants, Principal Component 1 (PC1), Principal Component 2 (PC2), Song Meter 4, Acoustic structures crying, PRAAT software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Song Meter (SM)4Device
Also called automatic record device
Their cries will be longitudinally registered using an automatic record device: Song Meter (SM)4 during 3 consecutive days and nights. This record will take place at 15 days of life, 1 and half months, 2 and half months and 3 and half months.
| Study group | Role | What they receive |
|---|---|---|
| Infant at the birth | Infant at the birth will be included. Their cries will be longitudinally registered using an automatic record device: Song Meter (SM)4 during 3 consecutive days and nights.
At every cry, parent should answer the questionnaire of cry in infant. Receives: Device: Song Meter (SM)4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2)
Comparison of acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2) with PRAAT software.
Measured: up to 3 and half months.
Secondary outcomes (1)
Questionnaire of cry in infant
At every cry, parent should answer at the questionnaire of cry in infant: context of the crying (situation), how he interpreted it (pain, hunger, discomfort, etc.), actions he undertook to calm the crying (reassurance, lift, change, breastfeeding), and if those they have been effective in comforting the baby.
Measured: up to 3 and half months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start16 Oct 2018
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ENES, CNRS 9197
- Responsible party
- Sponsor
- Investigators
- Nicolas MATHEVON, PhD, Study chair, Université Jean MONNET, Saint-Etienne, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716882
- Sponsor's protocol ID
- 18CH085
- Other IDs
- 2018-A01399-46
- Acronym
- LongCRY
- Status last verified
- Jan 2021
- First submitted
- 22 Oct 2018
- Last updated
- 1 Feb 2021
- 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 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification
- ClinicalTrials.gov ID
- NCT03716882
- Acronym / sponsor ID
- LongCRY / 18CH085
- Conditions
- Infants
- Keywords
- Infants, Principal Component 1 (PC1), Principal Component 2 (PC2), Song Meter 4, Acoustic structures crying, PRAAT software
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- ENES, CNRS 9197
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 23 Oct 2018 (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.
Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.
The cry phenomenon consists of complex acoustic signals produced by the vocal cords and filtered by the vocal tract. The vibrations frequency determines the fundamental frequency, itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a cry is modified during the passage through the upper airways forming broad bands called "resonance frequency" or "formants".
From the specificity of a crying sequence, it is possible to extract dynamic information and relate it to the perception that the adult has of it. Thus dynamic crying is often perceived by the adult as an imminent need of the baby.
Some studies have shown that a child's crying may change according to his degree of discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could vary along a continuum. These changes would explain why adult listeners would be able to dissociate crying babies of different intensities.
Conversely, an inappropriate response to crying could gradually generate disorders of the relationship between the baby and the parent.
However, despite their potential neuro-ethological interest, knowledge of information transmitted by babies's cry remains superficial. This could be related to the relatively obsolete techniques of recording or due to the lack of objective physiological data on babies 'cry. Finally, the perception and reactions of adults when they hear crying babies are not fully understood.
Detailed description
The objective of this study is to evaluate acoustic structures crying of infants from 1 to 4 months for to study individual acoustic signature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant at the birth | – | Device: Song Meter (SM)4Infant at the birth will be included. Their cries will be longitudinally registered using an automatic record device: Song Meter (SM)4 during 3 consecutive days and nights. At every cry, parent should answer the questionnaire of cry in infant. |
Who may qualify
- Ages
- 1 day to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants at the birth
Key inclusion criteria (6 listed)
- any safe term infants (> 37SA)
- eutrophic and in good health
- infants sleeping in bed with bars without baby nest
- form signed by the holder of parental authority.
- Parents affiliated to a social security scheme
Key exclusion criteria (5 listed)
- inter-uterine growth restriction
- antenatal neurological pathologies or at birth
- perinatal asphyxial encephalopathy
- antenatal pathologies (e.g. trisomy 21, hydrocephalus...)
- multiple pregnancy
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 |
|---|---|---|
| Song Meter (SM)4Also: automatic record deviceTheir cries will be longitudinally registered using an automatic record device: Song Meter (SM)4 during 3 consecutive days and nights. This record will take place at 15 days of life, 1 and half months, 2 and half months and 3 and half months. | Device | Infant at the birth |
Primary outcome
Acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2)
Time frame: up to 3 and half months.
Comparison of acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2) with PRAAT software.
1 secondary outcome
Questionnaire of cry in infant
Time frame: up to 3 and half months.
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 1 Feb 2021.
- 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.
Nicolas MATHEVON, PhD study chair
Université Jean MONNET, Saint-Etienne, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infants, 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 6 inclusion and 5 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 1 Feb 2021. 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?
Acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2) (time frame: up to 3 and half months.). 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 1 Feb 2021.