Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Apparent Life-Threatening Event in Infants Under One Year of Age

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Blood sample analysis will be blinded

Study Groups

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ALTE group

Infants aged between 28 days and 12 months presenting severe(s) syncope(s) requiring hospitalization, for which a cause was identified during hospitalization.

Group Type OTHER

Blood sample for specific analyzes

Intervention Type BIOLOGICAL

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)

iALTE group

Infant aged between 28 days and 12 months presenting a severe syncope(s) requiring hospitalization, for which no etiology was found during hospitalization.

Group Type OTHER

Blood sample for specific analyzes

Intervention Type BIOLOGICAL

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)

Interventions

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Blood 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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

28 Days

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No