NCT04849234

Brief Summary

Interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds. The description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life. Thanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

April 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2021

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

April 13, 2021

Last Update Submit

December 23, 2022

Conditions

Keywords

CryingApgar scoreInfant BehaviorFirst crydelivery roomextra uterine life

Outcome Measures

Primary Outcomes (2)

  • Fo : maximum fundamental frequency (Hz) of the cry

    Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software The F0 and Apgar score will be correlated

    During the first 15 minutes of life

  • Apgar score (0-10)

    The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting score ranges from zero to 10. The five criteria are : appearance, pulse, grimace, activity, respiration. The F0 and Apgar score will be correlated

    During the first 15 minutes of life

Secondary Outcomes (4)

  • Pitch of the cry (Hz) Crying acoustic structures

    During the first 15 minutes of life

  • roughness of the cry (Hz)

    During the first 15 minutes of life

  • Duration of cry (s)

    During the first 15 minutes of life

  • Number of cry

    During the first 15 minutes of life

Study Arms (1)

New born

New born population aged 37 Weeks of Amenorrhea (SA) to 42 Weeks of Amenorrhea (SA) will be included. Their cries will be longitudinally registered.

Behavioral: newborn cries

Interventions

newborn criesBEHAVIORAL

Their cries will be longitudinally registered from the age of birth until the first 15 minutes of birth using an automatic record device: Recorder ZOOM H4N. The wav-sized files obtained from each recording will then be analyzed indiscriminately via an acoustic processing script created for the PRAAT software® by the post-doctoral fellows of the ENES laboratory (Sensory NeuroEthology Team) on the site of the Faculty of Sciences of Saint-Etienne.

New born

Eligibility Criteria

Age1 Minute - 15 Minutes
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infant newborn

You may qualify if:

  • Infant born between 37 and 42 SA
  • Live infant at birth
  • Parent who received informed written information about the study

You may not qualify if:

  • \- Emergency after childbirth (haemorrhage)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Premature BirthCryingInfant Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNonverbal CommunicationCommunicationBehaviorChild Behavior

Study Officials

  • HUGUES PATURAL, MD PHD

    CHU ST ETIENNE FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 19, 2021

Study Start

April 1, 2021

Primary Completion

May 2, 2021

Study Completion

May 2, 2021

Last Updated

December 27, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations