Apparent Life-Threatening Event in Infants Under One Year of Age
Conditions
Keywords
Apparent Life-Threatening Event, ALTE, Sudden Infant Death
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.
Interventions
BIOLOGICALBlood sample for specific analyzes
Standard management of ALTE * Hospitalization in pediatric intensive care unit or pediatric emergencies * Etiologic research * Blood volume, 2.5mL in PaxGene® tube, for specific analyzes (M2R, AchE)
Sponsors
University Hospital, Strasbourg, France
Groupement Interrégional de Recherche Clinique et d'Innovation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Blood sample analysis will be blinded
Eligibility
Sex/Gender
ALL
Age
28 Days to 12 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscarinic M2 receptor mRNA expression in blood | At the admission in the hospital, within 24 hours after the inclusion in the study | Blood sample will be collected not later than 24 hours after the inclusion in the study and will be frozen until centralized analysis. A qRT-PCR will be performed for quantification of CHRM2 gene expression in blood (mRNA expression). Interim analysis with the 7-8 first samples per group together. Final analysis with all samples at the study completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acetylcholinesterase mRNA expression in blood | At the admission in the hospital, within 24 hours after the inclusion in the study. | Blood sample will be collected not later than 24 hours after the inclusion in the study and will be frozen until centralized analysis.. A qRT-PCR will be performed for quantification of ACHE gene expression in blood (mRNA expression). Interim analysis with the 7-8 first samples per group together. Final analysis with all samples at the study completion. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCharlie DE MELO, MD
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed