Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors (iALTE)
Primary Purpose
Apparent Life-Threatening Event in Infants Under One Year of Age
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample for specific analyzes
Sponsored by
About this trial
This is an interventional basic science trial for Apparent Life-Threatening Event in Infants Under One Year of Age focused on measuring Apparent Life-Threatening Event, ALTE, Sudden Infant Death
Eligibility 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)
Sites / Locations
- Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital
- Pediatric Intensive Care Unit - Brabois Hospital - Nancy University HospitalRecruiting
- Pediatric unit - Maison Blanche Hospital - Reims University HospitalRecruiting
- Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ALTE group
iALTE group
Arm Description
Infants aged between 28 days and 12 months presenting severe(s) syncope(s) requiring hospitalization, for which a cause was identified during hospitalization.
Infant aged between 28 days and 12 months presenting a severe syncope(s) requiring hospitalization, for which no etiology was found during hospitalization.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03278977
First Posted
August 31, 2017
Last Updated
June 28, 2022
Sponsor
University Hospital, Strasbourg, France
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation Est
1. Study Identification
Unique Protocol Identification Number
NCT03278977
Brief Title
Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
Acronym
iALTE
Official Title
Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation Est
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apparent Life-Threatening Event in Infants Under One Year of Age
Keywords
Apparent Life-Threatening Event, ALTE, Sudden Infant Death
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blood sample analysis will be blinded
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALTE group
Arm Type
Other
Arm Description
Infants aged between 28 days and 12 months presenting severe(s) syncope(s) requiring hospitalization, for which a cause was identified during hospitalization.
Arm Title
iALTE group
Arm Type
Other
Arm Description
Infant aged between 28 days and 12 months presenting a severe syncope(s) requiring hospitalization, for which no etiology was found during hospitalization.
Intervention Type
Biological
Intervention Name(s)
Blood sample for specific analyzes
Intervention Description
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 Measure Information:
Title
Muscarinic M2 receptor mRNA expression in blood
Description
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.
Time Frame
At the admission in the hospital, within 24 hours after the inclusion in the study
Secondary Outcome Measure Information:
Title
Acetylcholinesterase mRNA expression in blood
Description
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.
Time Frame
At the admission in the hospital, within 24 hours after the inclusion in the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal BOUSQUET, MD, PhD
Phone
(0)3 68 85 33 89
Ext
+33
Email
pascal.bousquet@unistra.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlie DE MELO, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérard THIRIEZ, MD PhD
Email
gerard.thiriez@univ-fcomte.fr
Facility Name
Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital
City
Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu MARIA
Email
m.maria@chru-nancy.fr
Facility Name
Pediatric unit - Maison Blanche Hospital - Reims University Hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad AKHAVI
Email
aakhavi@chu-reims.fr
Facility Name
Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie DE MELO, MD
Email
charlie.demelo@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Charlie DE MELO, MD
First Name & Middle Initial & Last Name & Degree
Angelo LIVOLSI, MD
First Name & Middle Initial & Last Name & Degree
Pauline HELMS, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
We'll reach out to this number within 24 hrs