Impact of Prevention of Safe Sleeping and Unexpected Infant Death (MinUTE)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Prevention & Control; Unexpected Infant Death; Safe Sleeping
• Intervention / Treatment: Other: Sleeping mode

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gaëlle SORIN; Phone Number: +33241354427; Email: gaelle.sorin@chu-angers.fr
• Study Contact Backup: Name: Elise HOUSSIN; Email: DRCI-Promotion-Interne@chu-angers.fr

Study Locations

• France
  • Angers, France, 49933
    • Chu Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Parents of children from 0 to 6 months consulting at the Pediatric Emergency Department of University Hospital of Angers.

Description

Inclusion Criteria:

• All parents consulting the Pediatric Emergency Department of University Hospital of Angers for their baby aged 0 to 6 months

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Emergencies babies	Other: Sleeping mode; Smoking habits, socio-professional category

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	During the interview of the family, about 1 hour

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 49RC25_0113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No