NCT01732978

Brief Summary

The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state. The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on parental response. The detailed study of the acoustic structure of crying and analysis of parental perception will determine the dynamics during the first weeks of life of this recognition, and the influence of factors such as parental presence, or breastfeeding . For this study is organized in three stages: first, the recording of the baby's crying Secondly, a listening test parental soundtracks and third analysis of the acoustic structure of crying and parental response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

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

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

November 20, 2012

Last Update Submit

October 22, 2018

Conditions

Keywords

Crying recordNewborn

Outcome Measures

Primary Outcomes (1)

  • Crying recorded

    The acoustic structure of crying recorded the first days of life will be analyzed and aims to characterize an individual signature and the dynamic function of time of this structure.

    Second day of life of the parent's child

Secondary Outcomes (1)

  • Biological correlation

    Second day of life of parents' child

Study Arms (1)

Babies

OTHER

Any child born in the University Hospital of Saint Etienne (inborn) whatever its term birth, hospitalized in a neonatal unit at the time of registration (after 37 weeks of gestation for preterm infants) or maternity

Behavioral: Crying record

Interventions

Crying recordBEHAVIORAL

Recording spontaneous crying is as soon as possible after birth. Crying is recorded twice during the first week of life. Listening tests: Tests will be conducted playbacks with the father and mother separately, and with a staff

Babies

Eligibility Criteria

AgeUp to 1 Week
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • born in the University Hospital of Saint Etienne (inborn) whatever its term birth

You may not qualify if:

  • Congenital oropharyngeal tract preventing vocalization physiological newborn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Study Officials

  • Nicolas MATHEVON, PhD

    Jean Monnet University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 26, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations