Informations générales (source: ClinicalTrials.gov)
Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors (iALTE)
Interventional
N/A
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
septembre 2018
décembre 2023
29 juin 2024
Apparent Life-Threatening Events (ALTE) in infants often lead to severe neurological
complications or to sudden death. In such situations, cardio-pediatricians and intensive
care physicians have no specific diagnosis or treatment. In a recent translational
research (INSERM-DHOS), our team has reported a myocardiac abnormality in a rabbit model
of vagal hyperreactivity which is also present in the human hearts of infants deceased
from sudden death, i.e. increased M2 muscarinic receptors (M2R) density associated with
compensative increased enzymatic activity and overexpression of acetylcholine esterase
(AchE). In a recent PHRC-I study (article in preparation), these abnormalities have also
been observed in the blood of patients, infants as well as adults, exhibiting severe
vagal syncopes. We observed, even more importantly, similar abnormalities in infants
under 1 year of age with very severe idiopathic ALTE (iALTE) compared with normal
subjects and with patients who presented ALTE with identified etiologies (JAMA Pediatric,
2016 May). The aim of this present study is to validate the overexpression of M2R as a
marker of risk of iALTE in infant under 1 year.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Pediatric unit - Maison Blanche Hospital - Reims University Hospital - 51092 - Reims - France | Ahmad AKHAVI | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital - 54500 - Nancy - France | Mathieu MARIA | Contact (sur clinicalTrials) | |||
| Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital - 67200 - Strasbourg - France | Charlie DE MELO, MD | Contact (sur clinicalTrials) | |||
| Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital - 25030 - Besançon - France | Gérard THIRIEZ, MD PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Infant aged between 28 days and 12 months, presenting severe syncope(s) requiring
medical management, hospitalized in a pediatric intensive care unit or pediatric
emergencies
- Consent signed and dated by the legal representatives
- Patients affiliated to a social security system
- Infant aged between 28 days and 12 months, presenting severe syncope(s) requiring
medical management, hospitalized in a pediatric intensive care unit or pediatric
emergencies
- Consent signed and dated by the legal representatives
- Patients affiliated to a social security system
- Infant with known cardiovascular, neurologic, infectious, toxic or metabolic
pathologies before enrollment (before the syncope)
- Subject on medication for more than 3 months before enrollment
- Impossibility to clearly inform the legal representatives (comprehension problems)
- Subject in exclusion period for clinical trial (previous or current study)