Clinical trial NCT06332521: Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment
Official title: Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Newborn; Vitality
Premature Infants
Infant Development
Keywords: Newborn
Crying
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 1100
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full-term baby \> 37 weeks Premature baby \< 37 weeks

Brief summary: 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).

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.

Primary outcomes:
measure: Fundamental frequency f0 (Hz)
timeFrame: At inclusion
measure: Bailey-4 quantitative scale
timeFrame: At 2 years
Secondary outcomes:
measure: Percentage voiced frames
timeFrame: At inclusion
measure: Harmonics of f0 (Hz)
timeFrame: At inclusion
measure: Median pitch f0 (Hz)
timeFrame: At inclusion
measure: Harmonicity (dB)
timeFrame: At inclusion
measure: Jitter (Percentage),
timeFrame: At inclusion
measure: Q25 (Percentage)
timeFrame: At inclusion
measure: Median Cepstral Peak Prominence (CPP) (dB)
timeFrame: At inclusion
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu de Saint-Etienne
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: HUGUES PATURAL, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint-Etienne University
name: Nicolas MATHEVON, PhD
role: STUDY_CHAIR
References: