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Идёт набор NCT06332521

Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

Наблюдательное Newborn; Vitality Premature Infants Infant Development

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Acoustic signal analysis method.
Кому может быть актуально
Состояния в реестре: Newborn; Vitality, Premature Infants, Infant Development. Базовые параметры: до 4 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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).

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Fundamental frequency f0 (Hz) [Срок оценки: At inclusion]
  • Bailey-4 quantitative scale [Срок оценки: At 2 years]
Вторичные конечные точки (7)
  • Percentage voiced frames [Срок оценки: At inclusion]
  • Harmonics of f0 (Hz) [Срок оценки: At inclusion]
  • Median pitch f0 (Hz) [Срок оценки: At inclusion]
  • Harmonicity (dB) [Срок оценки: At inclusion]
  • Jitter (Percentage), [Срок оценки: At inclusion]
  • Q25 (Percentage) [Срок оценки: At inclusion]
  • Median Cepstral Peak Prominence (CPP) (dB) [Срок оценки: At inclusion]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Chu de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT06332521 · 23CH296 · ANSM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗