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

NCT03278977 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-06-30

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

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)

Sponsors & Collaborators

  • Groupement Interrégional de Recherche Clinique et d'Innovation Est

    collaborator UNKNOWN

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Charlie DE MELO, MD · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278977 on ClinicalTrials.gov