Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

NCT ID: NCT06332521

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2028-03-01

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).

Conditions

Newborn; Vitality; Premature Infants; Infant Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

birth of term babies

Study of crying in a group of newborns (birth of term babies)

Acoustic signal analysis method

Intervention Type: OTHER

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.

Premature babies

Study of crying in a group of newborns (Premature babies )

Acoustic signal analysis method

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Maximum Eligible Age: 4 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HUGUES PATURAL, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHU DE SAINT-ETIENNE

Nicolas MATHEVON, PhD

Role: STUDY_CHAIR

Saint-Etienne University

Locations

Chu de Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

HUGUES PATURAL, MD-PhD

Role: CONTACT

hugues.patural@chu-st-etienne.fr

(0)4 77 82 85 42 ext. +33

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

23CH296

Identifier Type: -

Identifier Source: org_study_id