- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02366715
Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research
IMLEMENTATION OF High Flow Nasal Cannulae Therapy FOR THE TREATMENT OF BRONCHIOLITIS IN A GENERAL PEDIATRIC WARD - A RETROSPECTIVE AND PROSPECTIVE CLINICAL TRIAL
연구 개요
상세 설명
Supportive Care, Single Group Assignment, Open Label, Non-Randomized, Efficacy Study
The research is devised as follows:
Prospective section: We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents.
Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
Retrospective section: We will examine up to 200 cases of children aged 0-2 years hospitalized due to Bronchiolitis in Pediatrics C during 2014-2016 which were not enrolled in our research (due to lack of consent/unavailable HHHFNC etc.). We will compare clinical data and vital parameters between the groups treated with HHHFNC and those who were not.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Petah Tikva, 이스라엘
- 모병
- Schneider Medical Center of Israel
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연락하다:
- Eran Rom, MD
- 전화번호: +972-54-770-5626
- 이메일: Eranr2@clalit.org.il
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
in age interval, diagnosed with Bronchiolitis
Exclusion Criteria:
Chronic heart/lung disease, immunocompromised state
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HeatedHumidifiedHighFlowNasalCannula
Treatment for moderate-severe cases of Bronchiolitis while monitoring medical parameters
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We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co. [3] which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents. Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Bronchiolitis Severity Score grade
기간: during the 20-40 hours of the protocol
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The grade in the Bronchiolitis Severity Score (0-12) reflects a general improvement or deterioration in any of these 5 parameters - oxygen saturation, breath rate, general appearance, degree of dyspnea and lung auscultation result.
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during the 20-40 hours of the protocol
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CO2 pressure
기간: during the 20-40 hours of the protocol
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(in mmHg) measured by a transcutaneous sensor.
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during the 20-40 hours of the protocol
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Medical interventions
기간: during the 20-40 hours of the protocol
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Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics.
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during the 20-40 hours of the protocol
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Ability to take in food orally
기간: during the 20-40 hours of the protocol
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Whether the child has been able to feed - yes or no.
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during the 20-40 hours of the protocol
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Number of Pediatric Intensive Care Unit (PICU) admissions
기간: The whole hospitalization period of the child
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Whether the child needed admission to PICU
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The whole hospitalization period of the child
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공동 작업자 및 조사자
수사관
- 수석 연구원: Eran Rom, Dr., Schneider Children Medical Center of Israel
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .