The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home (PROCLIVE)

The inclined position at 30 ° in case of transient respiratory discomfort is recommended since the consensus conference of September 2000. This recommendation is based on a low level of evidence (grade C). This advice is found in the health book, and in many tips for parents. However, it does not comply with the recommendations of the American Academy of Pediatrics for sleeping on the back, on a firm mattress and without other objects in the bed.

70% of pediatricians advise this position in a specific medical context according to a study of Bellaïche conducted in 2013. 40% of parents use it for no particular reason.

Anatomically, the upper airways of infants are of reduced caliber, and therefore at risk of obstruction.

A study by Bergougnioux on the cases of MIN in infants wearing a wrap-around sling shows that the flexion of the neck causes the chin to be positioned against the chest and contributes to the suffocation of the infant. This is especially important in infants under 3 months whose neck muscles do not yet support the weight of the head.

The 2009 InVS national survey of unexpected infant deaths shows that bed crashes accounted for 11.1% of all deaths reported. Among unexplained deaths, maladaptive bedding was a contributing factor, including the use of a pillow in the bed in 24.3% of cases.

It was observed in the study by Kornhauser Cerar et al in 2009 that half-sitting in a car seat for an extended duration was at the origin of a significant desaturations rate, which was also found in the car bed group. The control group "hospital bed" was not subject to these desaturations. These results support the fact that only an adapted bedding that complies with the recommendations protects against asphyxiation.

Since 2016, INPES recommends in its advice sheet on bronchiolitis for parents, a flat bed on the back.

Hypothesis :

The inclined position in infants under one year of age is at risk of unexpected death of the infant by obstruction of the upper airways, because of the changes of position that it entails, including a risk of slipping at the bottom of the bed and of asphyxiation under the covers.

Study Overview

• Status: Unknown
• Conditions: Obstruction, Airway; Sudden; Death, Infant
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hôpital Femme Mère Enfant
  • Gleizé, France, 69400
    • Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Parents of infants from 0 to 12 months attending pediatric emergencies in 2 hospitals are interroged :

• Hôpital Femme Mere Enfant (Bron)
• Hôpital Nord-Ouest (Villefranche sur Saône) Are included infant from 0 to 12 months, lie in a proclive position while sleeping whose parents / parent authority holders informed about the terms of the study and agree to answer the questionnaire

Description

Inclusion Criteria:

• Infant from 0 to 12 months
• Lie in a proclive position while sleeping
• Whose parents / parent authority holders informed about the terms of the study and agree to answer the questionnaire

Exclusion Criteria:

• Refusal to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sliding of the infant in the bottom of his bed in inclined position during sleep	Sliding of the infant in the bottom of his bed in inclined position during sleep, reported by the parents during the questionnaire in the form of a closed question.	1 day

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Death, Sudden; Death; Respiratory Insufficiency; Infant Death; Sudden Infant Death; Airway Obstruction
• Other Study ID Numbers: 69HCL18_0161

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