Unexpected Infant DeathMinUTENCT07237360
Impact of Prevention of Safe Sleeping and Unexpected Infant Death
An observational study of Unexpected Infant Death and Prevention & Control, run by University Hospital, Angers at 1 site in France.
Trial summary
The sudden unexpected infant death (SUID) is defined as "the sudden death of a child aged from 1 month to 1 year who had been healthy until then, whereas nothing in his known history or in the history of events could have allowed him to predict". Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Unexpected Infant Death, Prevention & Control, Safe Sleeping
- What is being tested?
- Sleeping mode
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Parents of children from 0 to 6 months consulting at the Pediatric Emergency Department of University Hospital of Angers.
Who may be able to join
- All parents consulting the Pediatric Emergency Department of University Hospital of Angers for their baby aged 0 to 6 months
Who cannot join
- Any other person consulting for a baby aged 0 to 6 months who is not the parent of the baby: a grandparent, an uncle, an aunt, a childminder, the nursery manager, a friend of the parents, etc.
- Parent refusing the use of their data
- Parent and/or child under legal protection
- Parent who does not understand French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elise HOUSSIN contact
About this study
Official title: Impact in Pediatric Emergency Departments of a Systematic Individualized Interview Conducted by an Advanced Practice Nurse, on the Prevention of Safe Sleeping and Unexpected Infant Death, in a Population of Infants From 0 to 6 Months
The sudden unexpected infant death (SUID) is defined as "the sudden death of a child aged from 1 month to 1 year who had been healthy until then, whereas nothing in his known history or in the history of events could have allowed him to predict". In France, the French High Autority of Health (Haute Autorité de Santé (HAS)) has set the upper age limit at 2 years.
According to french statistics, between 250 and 350 babies die each year of unexpected infant death. It is the leading cause of infant mortality in developed countries, with all the devastating psychological, social and legal consequences for families. The national prevention campaigns for the "back to sleep" SUID carried out in the 1990s allowed a 75% decrease in the number of SUID. Yet, still at the moment, around 150 deaths could be avoided each year in France by respecting strict dorsal sleeping recommendations and a safe environment.
Read more
According to the SUID register of Nantes (France) of April 2024, 75% of deaths occur before the child's six months. The risk factors are mainly prematurity, exposure to tobacco (during and after pregnancy), and a sleeping mode not recommended by HAS. Indeed, on the day of death, 20% of babies were lying on their stomach or side, 30% shared their bed and 59% were lying in bedding at risk of containment or obstruction of the upper airway.
According to the database of National Association of Infant Death Unexpected Reference Centers since 2022, there has been a resurgence in the number of these deaths. This proves the urgency of prevention on this public health issue.
In parallel, we do not know why the number of SUID is not decreasing in correlation with the decrease in the birth rate in France. Moreover, it would be interesting to know the reasons why parents do not follow the recommendations of the HAS for their baby to sleep safely.
Thus, I wish to evaluate the impact of systematic prevention by the Advanced Practice Nurse with the parents of infants aged 0 to 6 months presenting to the Pediatric Emergency and know their barriers/levers to change.
My research question is therefore titled:
Why and how many infants under 6 months sleep in insecurity compared to lying babies according to the international recommendations ?
- Conditions
- Unexpected Infant Death, Prevention & Control, Safe Sleeping
- Being tested
- Sleeping mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeping modeOther
Smoking habits, socio-professional category
| Study group | Role | What they receive |
|---|---|---|
| Emergencies babies | Not described Receives: Other: Sleeping mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in the number of babies lying well on their backs after the guided interview VS the number of babies lying well on their backs before the guided interview
Measured: During the interview of the family, about 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexpected Infant DeathStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237360
- Sponsor's protocol ID
- 49RC25_0113
- Acronym
- MinUTE
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact in Pediatric Emergency Departments of a Systematic Individualized Interview Conducted by an Advanced Practice Nurse, on the Prevention of Safe Sleeping and Unexpected Infant Death, in a Population of Infants From 0 to 6 Months
- ClinicalTrials.gov ID
- NCT07237360
- Acronym / sponsor ID
- MinUTE / 49RC25_0113
- Conditions
- Unexpected Infant Death, Prevention & Control, Safe Sleeping
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
The sudden unexpected infant death (SUID) is defined as "the sudden death of a child aged from 1 month to 1 year who had been healthy until then, whereas nothing in his known history or in the history of events could have allowed him to predict". In France, the French High Autority of Health (Haute Autorité de Santé (HAS)) has set the upper age limit at 2 years.
According to french statistics, between 250 and 350 babies die each year of unexpected infant death. It is the leading cause of infant mortality in developed countries, with all the devastating psychological, social and legal consequences for families. The national prevention campaigns for the "back to sleep" SUID carried out in the 1990s allowed a 75% decrease in the number of SUID. Yet, still at the moment, around 150 deaths could be avoided each year in France by respecting strict dorsal sleeping recommendations and a safe environment.
According to the SUID register of Nantes (France) of April 2024, 75% of deaths occur before the child's six months. The risk factors are mainly prematurity, exposure to tobacco (during and after pregnancy), and a sleeping mode not recommended by HAS. Indeed, on the day of death, 20% of babies were lying on their stomach or side, 30% shared their bed and 59% were lying in bedding at risk of containment or obstruction of the upper airway.
According to the database of National Association of Infant Death Unexpected Reference Centers since 2022, there has been a resurgence in the number of these deaths. This proves the urgency of prevention on this public health issue.
In parallel, we do not know why the number of SUID is not decreasing in correlation with the decrease in the birth rate in France. Moreover, it would be interesting to know the reasons why parents do not follow the recommendations of the HAS for their baby to sleep safely.
Thus, I wish to evaluate the impact of systematic prevention by the Advanced Practice Nurse with the parents of infants aged 0 to 6 months presenting to the Pediatric Emergency and know their barriers/levers to change.
My research question is therefore titled:
Why and how many infants under 6 months sleep in insecurity compared to lying babies according to the international recommendations ?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergencies babies | – | Other: Sleeping mode |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parents of children from 0 to 6 months consulting at the Pediatric Emergency Department of University Hospital of Angers.
Key inclusion criteria (1 listed)
- All parents consulting the Pediatric Emergency Department of University Hospital of Angers for their baby aged 0 to 6 months
Key exclusion criteria (4 listed)
- Any other person consulting for a baby aged 0 to 6 months who is not the parent of the baby: a grandparent, an uncle, an aunt, a childminder, the nursery manager, a friend of the parents, etc.
- Parent refusing the use of their data
- Parent and/or child under legal protection
- Parent who does not understand French
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 |
|---|---|---|
| Sleeping modeSmoking habits, socio-professional category | Other | Emergencies babies |
Primary outcome
Increase in the number of babies lying well on their backs after the guided interview VS the number of babies lying well on their backs before the guided interview
Time frame: During the interview of the family, about 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Elise HOUSSIN contact
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 Unexpected Infant Death and Prevention & Control, run by University Hospital, Angers at 1 site 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 1 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: opening soon, as of the sponsor's last update on 19 Nov 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaëlle SORIN (+33241354427, gaelle.sorin@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in the number of babies lying well on their backs after the guided interview VS the number of babies lying well on their backs before the guided interview (time frame: During the interview of the family, about 1 hour). 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 19 Nov 2025.