- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00677066
Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis
A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis
연구 개요
상세 설명
Acute bronchiolitis is the most common reason for hospital admission in children aged less than 1 year in developed countries. Over the last 25 years, hospitalization rates and admission duration have increased dramatically, resulting in substantial health care costs for both institutions and individual families.
There are currently no pharmacological therapies for acute bronchiolitis that have been shown to consistently alter the natural history of this disease. Current evidence suggests that management is essentially supportive, consisting of oxygen supplementation if the child is hypoxic and nasogastric feeds or intravenous fluids if the child is dehydrated. Oxygen supplementation is the principal determinant of the length of hospital admission for children with acute bronchiolitis and the need for supplemental oxygen is generally considered to be an absolute indication for hospitalization. However, Bajaj et al demonstrated that a carefully selected population of children with acute bronchiolitis can be managed safely with home oxygen therapy.
The escalating demand and cost of health care has driven health reforms in many countries, including Australia and the United Kingdom. These reforms have included the development of services that allow patients with a range of illnesses to be managed safely in their own home rather than hospital. Such services have been well established for children with a number of chronic conditions and although managing children with acute illnesses at home is not a new strategy, this model of care is increasingly considered an alternative to traditional in-patient hospitalisation. In addition to the financial benefits of transferring care to the patients' homes for health care providers and families, children and parents report a strong preference for such models of care.
Home oxygen therapy is considered an appropriate and relatively safe option for children with chronic respiratory problems such as chronic lung disease of prematurity, but the use of home oxygen therapy for children with acute respiratory problems is limited. With the recent establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to determine the safety, parental satisfaction and economic advantage of home oxygen therapy for children with acute bronchiolitis compared with traditional inpatient hospitalization.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Western Australia
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Perth, Western Australia, 호주, 6001
- Princess Margaret Hospital for Children
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 3 - 24 months of age (corrected gestation)
- Clinical diagnosis of acute bronchiolitis
- Adequate feeding (>50% normal) & hydration
- O2 saturation >92% on <1litre/minute nasal cannula oxygen.
- Observed and clinically stable for at least 24 hours in hospital
- Pass modified "safety in air test "
- Caregivers must be counseled about risk of smoking around a child receiving oxygen supplementation
- Caregivers must be adequately educated about home oxygen
- HiTH nurses able to visit at home at least twice daily, in addition to daily phone call
- Paediatrician agrees that child is eligible for recruitment in study
Exclusion Criteria:
- Pre-existing cardiac, pulmonary (including chronic lung disease of infancy, cystic fibrosis and congenital or acquired airway anomalies), and neuromuscular disorders
- History of apnea
- Prematurity <34 weeks gestation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1
Children discharged home with oxygen
|
Administer oxygen at home or in hospital
다른 이름들:
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간섭 없음: 2
Children remain in hospital for oxygen therapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Readmission to hospital
기간: Within 7 days of discharge
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Within 7 days of discharge
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Number of days in hospital
기간: days
|
days
|
parent satisfaction
기간: discharge
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discharge
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공동 작업자 및 조사자
수사관
- 수석 연구원: Andrew C Martin, FRACP, Princess Margaret Hospital for Children
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .
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