Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

Infant Development Clinical Trial

— BABYCRY_1000  

Official title:

Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332521
• Other study ID #: 23CH296
• Secondary ID: ANSM
• Status: Recruiting
• Start date: March 20, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: HUGUES PATURAL, MD-PhD
• Phone: (0)4 77 82 85 42
• Email: hugues.patural[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Days

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development
• Newborn; Vitality
• Premature Infants

Intervention

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.

Locations

Country	Name	City	State
France	Chu de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fundamental frequency f0 (Hz)	Fundamental frequency f0 (Hz) defined from a crying sequence, the most characteristic elementary index of their individual bioacoustic signature.	At inclusion
Primary	Bailey-4 quantitative scale	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)	At 2 years
Secondary	Percentage voiced frames	Other bioacoustic characteristics measurable in each bioacoustic sequence	At inclusion
Secondary	Harmonics of f0 (Hz)	Other bioacoustic characteristics measurable in each bioacoustic sequence : vibration frequency of the vocal cords, defining a +/- low or high tone	At inclusion
Secondary	Median pitch f0 (Hz)	Other bioacoustic characteristics measurable in each bioacoustic sequence	At inclusion
Secondary	Harmonicity (dB)	Other bioacoustic characteristics measurable in each bioacoustic sequence	At inclusion
Secondary	Jitter (Percentage),	Other bioacoustic characteristics measurable in each bioacoustic sequence	At inclusion
Secondary	Q25 (Percentage)	Other bioacoustic characteristics measurable in each bioacoustic sequence : rapid amplitude fluctuations occurring at frequencies between 30 and 150 Hz	At inclusion
Secondary	Median Cepstral Peak Prominence (CPP) (dB)	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	At inclusion