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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482804
Recruitment Status : Unknown
Verified March 2018 by Hospices Civils de Lyon.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment
Obstruction, Airway Sudden; Death, Infant Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Questionnaires

    Parents will be interviewed before being seen in consultation in the emergency room. The reason for consultation will not be taken into account, the only criterion being the age of the child. There will be no sign in the waiting room, the study will be proposed to them by the principal investigator.

    The questionnaires will be collected on live paper. The answers will be transferred in a second time on an Excel database protected by a password.



Primary Outcome Measures :
  1. Sliding of the infant in the bottom of his bed in inclined position during sleep [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482804


Contacts
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Contact: Jean STAGNARA, Dr 0472830345 ext +33 jeanstagnara@wanadoo.fr

Locations
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France
Hôpital Femme Mère Enfant
Bron, France, 69677
Contact: Jean STAGNARA, Dr    0472830345 ext +33    jeanstagnara@wanadoo.fr   
Contact: Jacques VERMONT, Dr       jacques.vemont@chu-lyon.fr   
Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône
Gleizé, France, 69400
Contact: Philippe REBAUD, Dr    04 74 09 28 53 ext +33    prebaud@lhopitalnordouest.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03482804    
Other Study ID Numbers: 69HCL18_0161
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Airway Obstruction
Infant Death
Sudden Infant Death
Death
Pathologic Processes
Death, Sudden
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases