NCT03716882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

October 22, 2018

Last Update Submit

January 29, 2021

Conditions

Keywords

InfantsPrincipal Component 1 (PC1)Principal Component 2 (PC2)Song Meter 4Acoustic structures cryingPRAAT software

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Questionnaire of cry in infant

    up to 3 and half months.

Study Arms (1)

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

Interventions

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.

Also known as: automatic record device
Infant at the birth

Eligibility Criteria

Age1 Day - 10 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants at the birth

You may qualify if:

  • 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

You may not qualify if:

  • inter-uterine growth restriction
  • antenatal neurological pathologies or at birth
  • perinatal asphyxial encephalopathy
  • antenatal pathologies (e.g. trisomy 21, hydrocephalus...)
  • multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

Study Officials

  • Nicolas MATHEVON, PhD

    Université Jean MONNET, Saint-Etienne, France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 23, 2018

Study Start

October 16, 2018

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations