Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Bailey-4 quantitative scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Bailey-4 quantitative scale
时间窗: 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)
Fundamental frequency f0 (Hz)
时间窗: At inclusion
Fundamental frequency f0 (Hz) defined from a crying sequence, the most characteristic elementary index of their individual bioacoustic signature.
次要结局
- Median pitch f0 (Hz)(At inclusion)
- Q25 (Percentage)(At inclusion)
- Median Cepstral Peak Prominence (CPP) (dB)(At inclusion)
- Percentage voiced frames(At inclusion)
- Jitter (Percentage),(At inclusion)
- Harmonicity (dB)(At inclusion)
- Harmonics of f0 (Hz)(At inclusion)