Design of a Non-invasive Multi-modal Neonatal Monitoring System (VARI-NEONAT)
Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study
Studieöversikt
Detaljerad beskrivning
300 000 newborns per year are hospitalized in European neonatal units in the post-natal period. This is a critical period for neurobehavioral development and the establishment of an optimal model of sleep-wake cycle is fundamental for brain development.
The objective of the research is to develop new tools for computer-aided clinical and predictive diagnosis and real-time monitoring in neonatology.
The development of non-invasive sensors based on video and sound images aims to improve the short- and medium-term prognosis in perinatal patients.
To that aim, multi-modal composite indices integrating the image (which is used only to generate a quantification of the movement) and the sound to the bioelectric signals already available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic and prognostic information.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Rennes, Frankrike, 35000
- Rennes University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- newborns less than 6 weeks old in corrected terms;
newborns in one of the following situations:
- persistent discomfort (apneas);
- infection or suspicion of infection;
- premature with uncomplicated evolution;
- Premature brain lesion acquired in perinatal;
- newborn having been exposed to premature rupture of the membranes.
Exclusion Criteria:
- Congenital malformation;
- Metabolic disease.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Neonates
Babies born in Rennes University Hospital
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After parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed. At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Evolution of the cardiac variability during the stay in the ward
Tidsram: Up to 2 months
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The cardiac signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of cardiac variability.
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Up to 2 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evolution of the respiratory variability during the stay in the ward
Tidsram: Up to 2 months
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The respiratory signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of respiratory variability.
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Up to 2 months
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Evolution of the babies' movements during the stay in the ward
Tidsram: Up to 2 months
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Continuous video acquisitions of the newborns are realized.
Video images will be analyzed by specific routines to extract quantitative parameters of movements.
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Up to 2 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Patrick PLADYS, MD, PhD, Chu Rennes
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 35RC15_3012
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