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Trial record 3 of 36 for:    "sudden infant death"

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

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ClinicalTrials.gov Identifier: NCT03278977
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Groupement Interrégional de Recherche Clinique et d'Innovation Est
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Apparent Life-Threatening Event in Infants Under One Year of Age Biological: Blood sample for specific analyzes Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blood sample analysis will be blinded
Primary Purpose: Basic Science
Official Title: Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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)

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.
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)




Primary Outcome Measures :
  1. Muscarinic M2 receptor mRNA expression in blood [ Time Frame: 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 Outcome Measures :
  1. Acetylcholinesterase mRNA expression in blood [ Time Frame: 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.




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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278977


Contacts
Contact: Pascal BOUSQUET, MD, PhD (0)3 68 85 33 89 ext +33 pascal.bousquet@unistra.fr

Locations
France
Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital Not yet recruiting
Besançon, France, 25030
Contact: Gérard THIRIEZ, MD PhD       gerard.thiriez@univ-fcomte.fr   
Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital Recruiting
Nancy, France, 54500
Contact: Mathieu MARIA       m.maria@chru-nancy.fr   
Pediatric unit - Maison Blanche Hospital - Reims University Hospital Not yet recruiting
Reims, France, 51092
Contact: Ahmad AKHAVI       aakhavi@chu-reims.fr   
Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital Recruiting
Strasbourg, France, 67200
Contact: Charlie DE MELO, MD       charlie.demelo@chru-strasbourg.fr   
Principal Investigator: Charlie DE MELO, MD         
Sub-Investigator: Angelo LIVOLSI, MD         
Sub-Investigator: Pauline HELMS, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Groupement Interrégional de Recherche Clinique et d'Innovation Est
Investigators
Principal Investigator: Charlie DE MELO, MD Hôpitaux Universitaires de Strasbourg

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03278977     History of Changes
Other Study ID Numbers: 6432
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Strasbourg, France:
Apparent Life-Threatening Event
ALTE
Sudden Infant Death

Additional relevant MeSH terms:
Infant Death
Sudden Infant Death
Death
Pathologic Processes
Death, Sudden