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Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification (LongCRY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716882
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
ENES, CNRS 9197
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.


Condition or disease Intervention/treatment
Infants Device: Song Meter (SM)4

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.

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Study Type : Observational
Estimated Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Group/Cohort Intervention/treatment
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.

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.
Other Name: automatic record device




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Questionnaire of cry in infant [ Time Frame: up to 3 and half months. ]
    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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Ages Eligible for Study:   up to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants at the birth
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716882


Contacts
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Contact: Hugues PATURAL, PhD (0)4 77 82 85 42 ext +33 hugues.patural@chu-st-etienne.fr
Contact: Margueritte LOCKHART, Student (0)4 77 82 85 42 ext +33 margaux.bouron@wanadoo.fr

Locations
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France
Chu Saint-Etienne Recruiting
Saint-Étienne, France
Principal Investigator: Hugues PATURAL, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
ENES, CNRS 9197
Investigators
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Study Chair: Nicolas MATHEVON, PhD Université Jean MONNET, Saint-Etienne, France

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03716882    
Other Study ID Numbers: 18CH085
2018-A01399-46 ( Other Identifier: ANSM )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Infants
Principal Component 1 (PC1)
Principal Component 2 (PC2)
Song Meter 4
Acoustic structures crying
PRAAT software