Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant

It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom. Despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. The goal is to assess the impact of an information campaign of staffs maternity of the CHU of Reims on the practices of the sleeping of infants to motherhood, and then at the home of the parents.

Study Overview

• Status: Completed
• Conditions: Sudden Death in Children
• Intervention / Treatment: Other: Questionnaire on new born's bedding

Detailed Description

Proposal for participation to the holders of parental authority of newborns eligible within 72 hours after the birth of the child. If acceptance of participation, the newborn will be included in the study. Participation in the study will not affect the medical care of the child. Participation in the study will consist of: a collection of data including the child sleeping mode, complete a questionnaire covering the child sleeping habits to motherhood and home during the 1st month of life. Information on the habits of sleeping in the home of the child will be collected via a phone call by an investigator. Inclusions will be held over 2 periods: one before and one after the completion of training of health care personnel regarding the sleeping of infants nursing staff training will consist of oral information by the investigative team and written information...

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • Chu Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

every newborn

Description

Inclusion Criteria:

• born in reims CHU
• parents are 18 years old or more
• parents accept their participation in the study

Exclusion criteria :

• hospitalization in URIP / kangourou / neonatalogy
• needed baby warmer

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
New born group 1; New born who was born at the maternity of the CHU of Reims during a period of inclusion of one month, before nurses formation on the newborn's bedding	Other: Questionnaire on new born's bedding; Questionnaire on new born's bedding (Child's position in the bed : dorsal, ventral or lateral, presence of pillow or stuffed in bed, presence of coverage and presence of the bed sharing) at two times (during hospitalisation and one month later)
New born group 2; New born who was born at the maternity of the CHU of Reims during a period of inclusion of one month, after nurses formation on the newborn's bedding	Other: Questionnaire on new born's bedding; Questionnaire on new born's bedding (Child's position in the bed : dorsal, ventral or lateral, presence of pillow or stuffed in bed, presence of coverage and presence of the bed sharing) at two times (during hospitalisation and one month later)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correct new born's bedding	Newborn's bedding will be considered correct if the newborn is lying alone (no bed sharing), in exclusive dorsal position (no ventral or lateral position), in a bed without pillow, without blanket and without soft toy.	Day 0
correct new born's bedding	Newborn's bedding will be considered correct if the newborn is lying alone (no bed sharing), in exclusive dorsal position (no ventral or lateral position), in a bed without pillow, without blanket and without soft toy.	month 1

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): May 5, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death; Death, Sudden
• Other Study ID Numbers: PO19012

Drug and device information, study documents

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