- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04849234
Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life (FIRSTCRY)
FirstCRY Study : Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life
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.
Study Overview
Detailed Description
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. Aiming for this objective, many studies have already been carried out on infants crying in the first months of life, in order to better understand their significance (pain, discomfort, hunger) and the mechanisms of recognition and discrimination by parents or listeners. Various techniques are promising to characterize the acoustic space of cry (maximum frequency, intensity, harmonics, duration…).
However, few studies have investigated the acoustic characteristics of the first cry of life in the delivery room. Its intensity and characteristics are closely related to the laryngeal anatomy and respiratory capacity. Thus, a vigorous cry with its own acoustic characteristics could be the witness of a good adaptation to extra uterine life, while a weak or plaintive cry should warn the caregiver on difficulties in this adaptation.
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.
The investigators hypothesize that the acoustic characteristics of the first cries of newborns recorded at birth are correlated with the criteria of extra uterine life adaptation (Apgar score, pH and lactates collected from the umbilical cord), with the respiratory score (Silverman) and with the early neonatal outcome (transfer to the intensive care unit).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint-Étienne, France
- CHU Saint-Etienne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Infant born between 37 and 42 SA
- Live infant at birth
- Parent who received informed written information about the study
Exclusion Criteria:
- Emergency after childbirth (haemorrhage)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fo : maximum fundamental frequency (Hz) of the cry
Time Frame: During the first 15 minutes of life
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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
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Apgar score (0-10)
Time Frame: During the first 15 minutes of life
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pitch of the cry (Hz) Crying acoustic structures
Time Frame: During the first 15 minutes of life
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Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
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During the first 15 minutes of life
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roughness of the cry (Hz)
Time Frame: During the first 15 minutes of life
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Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
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During the first 15 minutes of life
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Duration of cry (s)
Time Frame: During the first 15 minutes of life
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Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
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During the first 15 minutes of life
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Number of cry
Time Frame: During the first 15 minutes of life
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Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
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During the first 15 minutes of life
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Collaborators and Investigators
Investigators
- Principal Investigator: HUGUES PATURAL, MD PHD, CHU ST ETIENNE FRANCE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBN262021/CHUSTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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