Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acoustic signal analysis method.
- Who it may be relevant to
- Registry conditions: Newborn; Vitality, Premature Infants, Infant Development. Basic parameters: up to 4 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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).
Interventions
- Other Acoustic signal analysis method
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.
Primary outcome measures
- Fundamental frequency f0 (Hz) [Time frame: At inclusion]
- Bailey-4 quantitative scale [Time frame: At 2 years]
Secondary outcome measures (7)
- Percentage voiced frames [Time frame: At inclusion]
- Harmonics of f0 (Hz) [Time frame: At inclusion]
- Median pitch f0 (Hz) [Time frame: At inclusion]
- Harmonicity (dB) [Time frame: At inclusion]
- Jitter (Percentage), [Time frame: At inclusion]
- Q25 (Percentage) [Time frame: At inclusion]
- Median Cepstral Peak Prominence (CPP) (dB) [Time frame: At inclusion]
Eligibility criteria
Inclusion criteria
- For a full-term baby > 37 weeks
- For a premature baby < 37 weeks
- Born in the maternity ward of the Saint-Etienne University Hospital
- Holder of parental authority having received informed information about the study and their right to object
- Holder of parental authority affiliated to or beneficiary of a social security system
- Eutrophic between the 10th and 90th percentile on the neonatal curves)
Exclusion criteria
- Refusal of participation by the holder of parental authority
- Antenatal pathology, nor perinatal asphyxia
- Holder of minor parental authority
- Holder of parental authority under curatorship or guardianship
- Abnormal T1 audiological screening test.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chu de Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT06332521 · 23CH296 · ANSM