- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Saint-Étienne, Frankrike
- Chu Saint-Etienne
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acoustic structures crying of parameters Principal Component 1 (PC1) and Principal Component 2 (PC2)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Questionnaire of cry in infant
Tidsramme: up to 3 and half months.
|
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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Nicolas MATHEVON, PhD, Université Jean MONNET, Saint-Etienne, France
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 18CH085
- 2018-A01399-46 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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