Chu de Saint-Etienne
Saint-Etienne, 42055, France
Location status: Recruiting
Location contact
Hugues PATURAL, MD-PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06332521
Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.
Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry.
Interested in participating?
Request InfoUp to 4 day
All sexes
Observational
Saint-Etienne, 42055, France
Location status: Recruiting
Hugues PATURAL, MD-PhD
PRINCIPAL_INVESTIGATOR
The objective of the Baby's cry 1000/100 study is to evaluate the acoustic characteristics of crying at birth, of term and premature babies and to correlate them with neurodevelopmental outcomes at 2 years of age to see if the bioacoustic characteristics of crying at birth could be predictive of the baby's neurofunctional integrity.
To achieve this objective, the investigators wish to document a large bank of recordings of the crying of term or premature babies by relying on deep learning and artificial intelligence approaches, making it possible to process large databases quickly, evaluate the links between acoustics of crying and clinical data at the birth of full-term babies who will benefit from systematic neurodevelopmental monitoring at 2 years (Bayley scale).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluate at birth in 2 characterized populations of babies born at term or prematurely, the correlation between bioacoustic characteristic of a cry specific to each baby, with the neurodevelopmental data at 2 years.
Time frame: At inclusion
Fundamental frequency f0 (Hz) defined from a crying sequence, the most characteristic elementary index of their individual bioacoustic signature.
Time frame: At 2 years
neurodevelopment at age 2 measured by the Bailey-4 quantitative scale. The final score is from 40 (Very weak neurodevelopment) to 160 (Very good neurodevelopment)
Time frame: At inclusion
Other bioacoustic characteristics measurable in each bioacoustic sequence
Time frame: At inclusion
Other bioacoustic characteristics measurable in each bioacoustic sequence : vibration frequency of the vocal cords, defining a +/- low or high tone
Time frame: At inclusion
Other bioacoustic characteristics measurable in each bioacoustic sequence
Time frame: At inclusion
Other bioacoustic characteristics measurable in each bioacoustic sequence
Time frame: At inclusion
Other bioacoustic characteristics measurable in each bioacoustic sequence
Time frame: At inclusion
Other bioacoustic characteristics measurable in each bioacoustic sequence : rapid amplitude fluctuations occurring at frequencies between 30 and 150 Hz
Time frame: At inclusion
The CPP makes it possible to quantify the "quality" of the voice and the acoustic signal and its degree of harmonicity as opposed to the severity of the dysphonia
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Saint Etienne
Other
Acronym: BABYCRY_1000
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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