- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03716882
Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification (LongCRY)
Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.
The cry phenomenon consists of complex acoustic signals produced by the vocal cords and filtered by the vocal tract. The vibrations frequency determines the fundamental frequency, itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a cry is modified during the passage through the upper airways forming broad bands called "resonance frequency" or "formants".
From the specificity of a crying sequence, it is possible to extract dynamic information and relate it to the perception that the adult has of it. Thus dynamic crying is often perceived by the adult as an imminent need of the baby.
Some studies have shown that a child's crying may change according to his degree of discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could vary along a continuum. These changes would explain why adult listeners would be able to dissociate crying babies of different intensities.
Conversely, an inappropriate response to crying could gradually generate disorders of the relationship between the baby and the parent.
However, despite their potential neuro-ethological interest, knowledge of information transmitted by babies's cry remains superficial. This could be related to the relatively obsolete techniques of recording or due to the lack of objective physiological data on babies 'cry. Finally, the perception and reactions of adults when they hear crying babies are not fully understood.
Aperçu de l'étude
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Saint-Étienne, France
- Chu Saint-Etienne
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- any safe term infants (> 37SA)
- eutrophic and in good health
- infants sleeping in bed with bars without baby nest
- form signed by the holder of parental authority.
- Parents affiliated to a social security scheme
- Parents who to live in cities of Saint-Etienne, Villars, Saint Priest-en-Jarez, Etrat and Saint Jean-Bonnefonds, France
Exclusion Criteria:
- inter-uterine growth restriction
- antenatal neurological pathologies or at birth
- perinatal asphyxial encephalopathy
- antenatal pathologies (e.g. trisomy 21, hydrocephalus...)
- multiple pregnancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Infant at the birth
Infant at the birth will be included. Their cries will be longitudinally registered using an automatic record device: Song Meter (SM)4 during 3 consecutive days and nights. At every cry, parent should answer the questionnaire of cry in infant. |
Their cries will be longitudinally registered using an automatic record device: Song Meter (SM)4 during 3 consecutive days and nights.
This record will take place at 15 days of life, 1 and half months, 2 and half months and 3 and half months.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2)
Délai: up to 3 and half months.
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Comparison of acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2) with PRAAT software.
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up to 3 and half months.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Questionnaire of cry in infant
Délai: up to 3 and half months.
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At every cry, parent should answer at the questionnaire of cry in infant: context of the crying (situation), how he interpreted it (pain, hunger, discomfort, etc.), actions he undertook to calm the crying (reassurance, lift, change, breastfeeding), and if those they have been effective in comforting the baby.
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up to 3 and half months.
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Nicolas MATHEVON, PhD, Université Jean MONNET, Saint-Etienne, France
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 18CH085
- 2018-A01399-46 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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