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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03716882
Other study ID # 18CH085
Secondary ID 2018-A01399-46
Status Completed
Phase
First received
Last updated
Start date October 16, 2018
Est. completion date January 6, 2020

Study information

Verified date January 2021
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date January 6, 2020
Est. primary completion date January 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 10 Weeks
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Song Meter (SM)4
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.

Locations

Country Name City State
France Chu Saint-Etienne Saint-Étienne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne ENES, CNRS 9197

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 3 and half months.
Secondary 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. up to 3 and half months.
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