Premature Birth Clinical Trial
— FIRSTCRYOfficial title:
FirstCRY Study : Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life
NCT number | NCT04849234 |
Other study ID # | IRBN262021/CHUSTE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | May 2, 2021 |
Verified date | December 2022 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | May 2, 2021 |
Est. primary completion date | May 2, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 1 Minute to 15 Minutes |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | Chu Saint-Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Pitch of the cry (Hz) Crying acoustic structures | Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software | During the first 15 minutes of life | |
Secondary | roughness of the cry (Hz) | Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software | During the first 15 minutes of life | |
Secondary | Duration of cry (s) | Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software | During the first 15 minutes of life | |
Secondary | Number of cry | Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software | During the first 15 minutes of life |
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