- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03482804
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.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Bron, 프랑스, 69677
- Hôpital Femme Mère Enfant
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Gleizé, 프랑스, 69400
- Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sliding of the infant in the bottom of his bed in inclined position during sleep
기간: 1 day
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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.
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1 day
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Obstruction, Airway에 대한 임상 시험
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Sohag University아직 모집하지 않음Supra Glottic Airway 장치를 사용한 측두하악 관절 기능의 변화
Questionnaires에 대한 임상 시험
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University Hospital, BordeauxRestless Legs Syndrome Foundation모병