Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment (NCT06332521) | Clinical Trial Compass
RecruitingNot Applicable
Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment
France1,100 participantsStarted 2024-03-20
Plain-language 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.
Who can participate
Age range
4 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fundamental frequency f0 (Hz)
Timeframe: At inclusion
2
Bailey-4 quantitative scale
Timeframe: At 2 years
Trial details
NCT IDNCT06332521
SponsorCentre Hospitalier Universitaire de Saint Etienne