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
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.
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|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|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|
- 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.
- 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.
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
|Contact: Jean STAGNARA, Dr||0472830345 ext +firstname.lastname@example.org|
|Hôpital Femme Mère Enfant|
|Bron, France, 69677|
|Contact: Jean STAGNARA, Dr 0472830345 ext +33 email@example.com|
|Contact: Jacques VERMONT, Dr firstname.lastname@example.org|
|Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône|
|Gleizé, France, 69400|
|Contact: Philippe REBAUD, Dr 04 74 09 28 53 ext +33 email@example.com|