Sudden Infant DeathSIDSNCT06060249
Investigation of the Genetic Diseases in Infants With Unknown Cause of Death
An observational study of Sudden Infant Death, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Sudden infant death syndrome (SIDS) is a disease of an infant under one year of age, whose sudden death occurred unexpectedly, which the cause of death cannot be determined despite macro-autopsy, and toxicological, pathological and microbiological examinations. It is most common in babies aged 2-4 months. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Sudden Infant Death
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jan 2025
- Phase
- Observational
- 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: This research project was planned as a prospective, descriptive, open uncontrolled study. The duration of the project is foreseen as 12 months. Approval for our research was received from Ankara University Human Research Ethics Committee.
Who may be able to join
- Under one year of age, who died unexpectedly and suddenly, whose cause of death could not be determined despite the death examination, autopsy, toxicological, pathological and microbiological examinations carried out on the internal organ samples and body fluids taken during the autopsy by the Forensic Medicine Institute Ankara Group Presidency between 2018 and 2023.
- Witness blood samples taken during the autopsies of the patients will be evaluated, and peripheral blood samples of 100 patients, stored under appropriate conditions, will be transferred to the genetic laboratory for DNA isolation and genetic study.
Who cannot join
- Patients with findings indicating congenital structural anomalies or known genetic syndromes during autopsy will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Sudden infant death syndrome (SIDS) is a disease of an infant under one year of age, whose sudden death occurred unexpectedly, which the cause of death cannot be determined despite macro-autopsy, and toxicological, pathological and microbiological examinations. It is most common in babies aged 2-4 months. Although it cannot be attributed to a single cause, it is suggested that apnea/airway obstruction, abuse, developmental disorders, exposure to cigarette smoke, infections, toxic gases, metabolic diseases, and cardiac problems cause SIDS. It is known that genetic studies on SIDS are few and the literature reported so far is insufficient. On the other hand, as a result of rapid developments in genetic diagnosis methods, various genes associated with SIDS have been reported in recent studies. Most of the studies conducted include genetic studies aimed at investigating specific disease groups in SIDS. Although there are few studies on comprehensive investigation of genetic causes, potentially causative variants have been identified in 20% of cases where whole exome sequencing has been performed. In a study including perinatal deaths in which the reports of the Forensic Medicine Institute in our country were examined, 4% of the cases were reported as infant deaths of unknown cause. However, this study is only autopsy data and does not include metabolic and genetic examinations. For this reason, as far as we know, there is no information about the incidence of SIDS in our country.
Based on this information, in our research, in the province of Ankara, the deaths of children under one year of age who died unexpectedly and suddenly were examined, autopsied, and toxicological examinations were performed on internal organ samples and body fluids taken during the autopsy by the Ankara Group Presidency of the Forensic Medicine Institute between 2018 and 2023. Genetic investigation of hereditary diseases that may lead to death of cases whose cause of death cannot be explained despite pathological and microbiological examinations will be carried out by the Whole Exome Sequencing (WES) method.
The project will be carried out by researchers at Ankara University Faculty of Medicine and Forensic Medicine Institute Ankara Group Presidency. This research project was planned as a prospective, descriptive, open uncontrolled study. The duration of the project is foreseen as 12 months. Approval for our research was received from Ankara University
- Conditions
- Sudden Infant Death
- Medical subject headings
- Sudden Infant Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic diseases have an important place among the causes of sudden infant death syndrome
if a preventable cause of hereditary death is found, the families of children whose genetic cause or causes are determined are informed about the genetic disease or diseases detected, in order to prevent the occurrence of these diseases in the next pregnancy or in future generations or relatives
Measured: 1-2 years
Secondary outcomes (1)
Genetic diseases have an important place among the causes of sudden infant death
To lead the initiation of studies to detect undetected cases, to contribute to the decrease in the mortality rate of infants under one year of age (Infant mortality rate) and the mortality rate of under 5 years of age, which indicate the level of development of a country's child health and child health services, and to lead the development of preventive services for child health in our country
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Infant DeathStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATICE MUTLU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060249
- Sponsor's protocol ID
- SIDS2023
- Acronym
- SIDS
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Genetic Diseases in Infants With Unknown Cause of Death
- ClinicalTrials.gov ID
- NCT06060249
- Acronym / sponsor ID
- SIDS / SIDS2023
- Conditions
- Sudden Infant Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 29 Sep 2023 (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.
Sudden infant death syndrome (SIDS) is a disease of an infant under one year of age, whose sudden death occurred unexpectedly, which the cause of death cannot be determined despite macro-autopsy, and toxicological, pathological and microbiological examinations. It is most common in babies aged 2-4 months. Although it cannot be attributed to a single cause, it is suggested that apnea/airway obstruction, abuse, developmental disorders, exposure to cigarette smoke, infections, toxic gases, metabolic diseases, and cardiac problems cause SIDS. It is known that genetic studies on SIDS are few and the literature reported so far is insufficient. On the other hand, as a result of rapid developments in genetic diagnosis methods, various genes associated with SIDS have been reported in recent studies. Most of the studies conducted include genetic studies aimed at investigating specific disease groups in SIDS. Although there are few studies on comprehensive investigation of genetic causes, potentially causative variants have been identified in 20% of cases where whole exome sequencing has been performed. In a study including perinatal deaths in which the reports of the Forensic Medicine Institute in our country were examined, 4% of the cases were reported as infant deaths of unknown cause. However, this study is only autopsy data and does not include metabolic and genetic examinations. For this reason, as far as we know, there is no information about the incidence of SIDS in our country.
Based on this information, in our research, in the province of Ankara, the deaths of children under one year of age who died unexpectedly and suddenly were examined, autopsied, and toxicological examinations were performed on internal organ samples and body fluids taken during the autopsy by the Ankara Group Presidency of the Forensic Medicine Institute between 2018 and 2023. Genetic investigation of hereditary diseases that may lead to death of cases whose cause of death cannot be explained despite pathological and microbiological examinations will be carried out by the Whole Exome Sequencing (WES) method.
The project will be carried out by researchers at Ankara University Faculty of Medicine and Forensic Medicine Institute Ankara Group Presidency. This research project was planned as a prospective, descriptive, open uncontrolled study. The duration of the project is foreseen as 12 months. Approval for our research was received from Ankara University
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This research project was planned as a prospective, descriptive, open uncontrolled study. The duration of the project is foreseen as 12 months. Approval for our research was received from Ankara University Human Research Ethics Committee.
Key inclusion criteria (2 listed)
- Under one year of age, who died unexpectedly and suddenly, whose cause of death could not be determined despite the death examination, autopsy, toxicological, pathological and microbiological examinations carried out on the internal organ samples and body fluids taken during the autopsy by the Forensic Medicine Institute Ankara Group Presidency between 2018 and 2023.
- Witness blood samples taken during the autopsies of the patients will be evaluated, and peripheral blood samples of 100 patients, stored under appropriate conditions, will be transferred to the genetic laboratory for DNA isolation and genetic study.
Key exclusion criteria (1 listed)
- Patients with findings indicating congenital structural anomalies or known genetic syndromes during autopsy will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic diseases have an important place among the causes of sudden infant death syndrome
Time frame: 1-2 years
if a preventable cause of hereditary death is found, the families of children whose genetic cause or causes are determined are informed about the genetic disease or diseases detected, in order to prevent the occurrence of these diseases in the next pregnancy or in future generations or relatives
1 secondary outcome
Genetic diseases have an important place among the causes of sudden infant death
Time frame: 5-10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
Related trials for Sudden Infant Death
Recruiting
Infant Safe Sleep in Pediatric Emergency Depratment
Infant Safe Sleep Practices, SIDS
Enrolling by invitationPhase 2/3
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Mucopolysaccharidosis II
Active, not recruitingPhase 2/3
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
Mucopolysaccharidosis Type II, Metabolic Diseases
Active, not recruitingPhase 2/3
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)
Mucopolysaccharidosis II
Active, not recruitingObservational study
Long-term Follow-Up for RGX-121
Mucopolysaccharidosis II
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Infant Death, run by Ankara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
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?
Genetic diseases have an important place among the causes of sudden infant death syndrome (time frame: 1-2 years). 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 29 Sep 2023.