Apparent Life-Threatening Event in Infants Under One Year of AgeiALTENCT03278977
Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
A study testing Blood sample for specific analyzes in people with Apparent Life-Threatening Event in Infants Under One Year of Age, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 12 months
- Conditions the study is for
- Apparent Life-Threatening Event in Infants Under One Year of Age
- What is being tested?
- Blood sample for specific analyzes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Sep 2018to 11 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital
Besançon, 25030
Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital
Nancy, 54500
Pediatric unit - Maison Blanche Hospital - Reims University Hospital
Reims, 51092
Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital
Strasbourg, 67200
About this study
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.
- Being tested
- Blood sample for specific analyzes
- Keywords
- Apparent Life-Threatening Event, ALTE, Sudden Infant Death
- Medical subject headings
- Brief, Resolved, Unexplained Event, Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample for specific analyzesBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Blood sample for specific analyzes |
| 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. Receives: Biological: Blood sample for specific analyzes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the admission in the hospital, within 24 hours after the inclusion in the study
Secondary outcomes (1)
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.
Measured: At the admission in the hospital, within 24 hours after the inclusion in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start15 Sep 2018
- Primary completion11 May 2022
- Study completion11 May 2022
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apparent Life-Threatening Event in Infants Under One Year of AgeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Charlie DE MELO, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278977
- Sponsor's protocol ID
- 6432
- Acronym
- iALTE
- Status last verified
- Jun 2022
- First submitted
- 31 Aug 2017
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
- ClinicalTrials.gov ID
- NCT03278977
- Acronym / sponsor ID
- iALTE / 6432
- Keywords
- Apparent Life-Threatening Event, ALTE, Sudden Infant Death
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALTE group | Other | Biological: Blood sample for specific analyzesInfants 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 | Biological: Blood sample for specific analyzesInfant aged between 28 days and 12 months presenting a severe syncope(s) requiring hospitalization, for which no etiology was found during hospitalization. |
Who may qualify
- Ages
- 28 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample for specific analyzesStandard 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) | Biological | ALTE group, iALTE group |
Primary outcome
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.
1 secondary outcome
Acetylcholinesterase mRNA expression in blood
Time frame: At the admission in the hospital, within 24 hours after the inclusion in the study.
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie DE MELO, MD principal investigator
Hôpitaux Universitaires de Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample for specific analyzes in people with Apparent Life-Threatening Event in Infants Under One Year of Age, run by University Hospital, Strasbourg, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscarinic M2 receptor mRNA expression in blood (time frame: At the admission in the hospital, within 24 hours after the inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.