- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716882
Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification (LongCRY)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint-Étienne, France
- Chu Saint-Etienne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- inter-uterine growth restriction
- antenatal neurological pathologies or at birth
- perinatal asphyxial encephalopathy
- antenatal pathologies (e.g. trisomy 21, hydrocephalus...)
- multiple pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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. |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2)
Time Frame: up to 3 and half months.
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Comparison of acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2) with PRAAT software.
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up to 3 and half months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Questionnaire of cry in infant
Time Frame: up to 3 and half months.
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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.
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up to 3 and half months.
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Nicolas MATHEVON, PhD, Université Jean MONNET, Saint-Etienne, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18CH085
- 2018-A01399-46 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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