Newborn; VitalityBABYCRY_1000NCT06332521
Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment
An observational study of Newborn; Vitality and Premature Infants, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn; Vitality, Premature Infants, Infant Development
- What is being tested?
- Acoustic signal analysis method
- How many people
- 1,100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2024to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full-term baby > 37 weeks Premature baby < 37 weeks
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu de Saint-Etienne
Saint-Etienne, 42055
Hugues PATURAL, MD-PhD
About this study
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.
Read the 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
- Being tested
- Acoustic signal analysis method
- Keywords
- Newborn, Crying
- Medical subject headings
- Premature Birth, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic signal analysis methodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| birth of term babies | Study of crying in a group of newborns (birth of term babies) Receives: Other: Acoustic signal analysis method | |
| Premature babies | Study of crying in a group of newborns (Premature babies ) Receives: Other: Acoustic signal analysis method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundamental frequency f0 (Hz)
Fundamental frequency f0 (Hz) defined from a crying sequence, the most characteristic elementary index of their individual bioacoustic signature.
Measured: 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)
Measured: At 2 years
Secondary outcomes (7)
Percentage voiced frames
Other bioacoustic characteristics measurable in each bioacoustic sequence
Measured: 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
Measured: At inclusion
Median pitch f0 (Hz)
Other bioacoustic characteristics measurable in each bioacoustic sequence
Measured: At inclusion
Harmonicity (dB)
Other bioacoustic characteristics measurable in each bioacoustic sequence
Measured: At inclusion
Jitter (Percentage),
Other bioacoustic characteristics measurable in each bioacoustic sequence
Measured: At inclusion
Q25 (Percentage)
Other bioacoustic characteristics measurable in each bioacoustic sequence : rapid amplitude fluctuations occurring at frequencies between 30 and 150 Hz
Measured: 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
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start20 Mar 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn; VitalityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUGUES PATURAL, MD-PhD, Principal investigator, CHU DE SAINT-ETIENNENicolas MATHEVON, PhD, Study chair, Saint-Etienne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332521
- Sponsor's protocol ID
- 23CH296
- Other IDs
- ANSM
- Acronym
- BABYCRY_1000
- Status last verified
- May 2025
- First submitted
- 20 Mar 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment
- ClinicalTrials.gov ID
- NCT06332521
- Acronym / sponsor ID
- BABYCRY_1000 / 23CH296
- Conditions
- Newborn; Vitality, Premature Infants, Infant Development
- Keywords
- Newborn, Crying
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| birth of term babies | – | Other: Acoustic signal analysis methodStudy of crying in a group of newborns (birth of term babies) |
| Premature babies | – | Other: Acoustic signal analysis methodStudy of crying in a group of newborns (Premature babies ) |
Who may qualify
- Ages
- Up to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full-term baby > 37 weeks Premature baby < 37 weeks
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic signal analysis methodEvaluate 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. | Other | Premature babies, birth of term babies |
Primary outcome
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.
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)
7 secondary outcomes
Percentage voiced frames
Time frame: At inclusion
Harmonics of f0 (Hz)
Time frame: At inclusion
Median pitch f0 (Hz)
Time frame: At inclusion
Harmonicity (dB)
Time frame: At inclusion
Jitter (Percentage),
Time frame: At inclusion
Q25 (Percentage)
Time frame: At inclusion
Median Cepstral Peak Prominence (CPP) (dB)
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HUGUES PATURAL, MD-PhD principal investigator
CHU DE SAINT-ETIENNE
Nicolas MATHEVON, PhD study chair
Saint-Etienne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn; Vitality and Premature Infants, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HUGUES PATURAL, MD-PhD ((0)4 77 82 85 42 ext. +33, hugues.patural@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundamental frequency f0 (Hz) (time frame: At inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.