Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment (BABYCRY_1000)

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Infants; Newborn; Vitality; Infant Development
• Intervention / Treatment: Other: Acoustic signal analysis method

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).

• Study Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: HUGUES PATURAL, MD-PhD; Phone Number: +33 (0)4 77 82 85 42; Email: hugues.patural@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Recruiting
    • CHU DE SAINT-ETIENNE
    • Principal Investigator: Hugues PATURAL, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
birth of term babies; Study of crying in a group of newborns (birth of term babies)	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.
Premature babies; Study of crying in a group of newborns (Premature babies )	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage voiced frames	Other bioacoustic characteristics measurable in each bioacoustic sequence	At inclusion
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
Median pitch f0 (Hz)	Other bioacoustic characteristics measurable in each bioacoustic sequence	At inclusion
Harmonicity (dB)	Other bioacoustic characteristics measurable in each bioacoustic sequence	At inclusion
Jitter (Percentage),	Other bioacoustic characteristics measurable in each bioacoustic sequence	At inclusion
Q25 (Percentage)	Other bioacoustic characteristics measurable in each bioacoustic sequence : rapid amplitude fluctuations occurring at frequencies between 30 and 150 Hz	At inclusion
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: HUGUES PATURAL, MD-PhD, CHU DE SAINT-ETIENNE; Study Chair: Nicolas MATHEVON, PhD, Saint-Etienne University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Newborn; Crying
• Other Study ID Numbers: 23CH296; ANSM (Other Identifier: 2024-A00286-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No