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

• ClinicalTrials.gov Identifier: NCT03716882
• Recruitment Status: Completed
• First Posted: October 23, 2018
• Last Update Posted: February 1, 2021
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborator: ENES, CNRS 9197
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Study Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 25 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
• Actual Primary Completion Date: January 6, 2020
• Actual Study Completion Date: January 6, 2020

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Chu Saint-Etienne

Saint-Étienne, France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

ENES, CNRS 9197

Investigators

• Study Chair: Nicolas MATHEVON, PhD; Université Jean MONNET, Saint-Etienne, France

More Information

• 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
• Last Update Posted: February 1, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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