Obstruction, Airway Clinical Trial
— PROCLIVEOfficial 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
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.
| Status | Not yet recruiting |
| Enrollment | 90 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A to 12 Months |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Femme Mère Enfant | Bron | |
| France | Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône | Gleizé |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |