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recruitment difficulties
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| Name | Class |
|---|---|
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTE group | Other | Infants aged between 28 days and 12 months presenting severe(s) syncope(s) requiring hospitalization, for which a cause was identified during hospitalization. |
|
| iALTE group | Other | Infant aged between 28 days and 12 months presenting a severe syncope(s) requiring hospitalization, for which no etiology was found during hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample for specific analyzes | Biological | Standard management of ALTE
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscarinic M2 receptor mRNA expression in blood | 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. | At the admission in the hospital, within 24 hours after the inclusion in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Acetylcholinesterase mRNA expression in blood | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlie DE MELO, MD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital | Besançon | 25030 | France | |||
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| ID | Term |
|---|---|
| D057768 | Brief, Resolved, Unexplained Event |
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D003490 | Cyanosis |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood sample analysis will be blinded
| At the admission in the hospital, within 24 hours after the inclusion in the study. |
| Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital |
| Nancy |
| 54500 |
| France |
| Pediatric unit - Maison Blanche Hospital - Reims University Hospital | Reims | 51092 | France |
| Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital | Strasbourg | 67200 | France |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D066088 | Infant Death |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |