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NCT Number: NCT06332521

Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

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.

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Key information

Age range

Up to 4 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Hugues PATURAL, MD-PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Fundamental frequency f0 (Hz)

    Time frame: At inclusion

    Fundamental frequency f0 (Hz) defined from a crying sequence, the most characteristic elementary index of their individual bioacoustic signature.

  2. Bailey-4 quantitative scale

    Time frame: At 2 years

    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)

Secondary outcomes

  1. Percentage voiced frames

    Time frame: At inclusion

    Other bioacoustic characteristics measurable in each bioacoustic sequence

  2. Harmonics of f0 (Hz)

    Time frame: At inclusion

    Other bioacoustic characteristics measurable in each bioacoustic sequence : vibration frequency of the vocal cords, defining a +/- low or high tone

  3. Median pitch f0 (Hz)

    Time frame: At inclusion

    Other bioacoustic characteristics measurable in each bioacoustic sequence

  4. Harmonicity (dB)

    Time frame: At inclusion

    Other bioacoustic characteristics measurable in each bioacoustic sequence

  5. Jitter (Percentage),

    Time frame: At inclusion

    Other bioacoustic characteristics measurable in each bioacoustic sequence

  6. Q25 (Percentage)

    Time frame: At inclusion

    Other bioacoustic characteristics measurable in each bioacoustic sequence : rapid amplitude fluctuations occurring at frequencies between 30 and 150 Hz

  7. Median Cepstral Peak Prominence (CPP) (dB)

    Time frame: At inclusion

    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

Study contacts

Contact information is provided by the study sponsor or research team.

HUGUES PATURAL, MD-PhD

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: BABYCRY_1000

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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