Clinical trial NCT03278977: Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
Official title: Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apparent Life-Threatening Event in Infants Under One Year of Age
Keywords: Apparent Life-Threatening Event
ALTE
Sudden Infant Death
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Groupement Interrégional de Recherche Clinique et d'Innovation Est
First posted: 2017-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 28
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Muscarinic M2 receptor mRNA expression in blood
timeFrame: At the admission in the hospital, within 24 hours after the inclusion in the study
Secondary outcomes:
measure: Acetylcholinesterase mRNA expression in blood
timeFrame: At the admission in the hospital, within 24 hours after the inclusion in the study.
Other outcomes:
Locations:
city: Besançon
country: France
facility: Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital
city: Nancy
country: France
facility: Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital
city: Reims
country: France
facility: Pediatric unit - Maison Blanche Hospital - Reims University Hospital
city: Strasbourg
country: France
facility: Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Charlie DE MELO, MD
role: PRINCIPAL_INVESTIGATOR
References: