Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

NCT06332521 | Recruiting

• 2 other identifiers: 23CH296ANSM
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn; Vitality; Premature Infants; Infant Development

Keywords

Newborn; Crying

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Percentage voiced frames

  At inclusion

• Harmonics of f0 (Hz)

  At inclusion

• Median pitch f0 (Hz)

  At inclusion

• Harmonicity (dB)

  At inclusion

• Jitter (Percentage),

  At inclusion

Study Arms (2)

birth of term babies

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

Other: Acoustic signal analysis method

Premature babies

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

Other: Acoustic signal analysis method

Interventions

Acoustic signal analysis method 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; birth of term babies

Eligibility Criteria

• Age: Up to 4 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Full-term baby \> 37 weeks Premature baby \< 37 weeks

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Premature Birth; Crying

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nonverbal Communication; Communication; Behavior

Study Officials

• HUGUES PATURAL, MD-PhD

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

• Nicolas MATHEVON, PhD

  Saint-Etienne University

  STUDY CHAIR

Central Study Contacts

HUGUES PATURAL, MD-PhD

CONTACT

(0)4 77 82 85 42; hugues.patural@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)