- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04905732
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
Nasal High-frequency Oscillatory Ventilation (NHFOV) vs Nasal Continuous Positive Airway Pressure(NCPAP) for Ventilated Newborn Infants With BPD: a Randomized Controlled Trial
연구 개요
상태
상세 설명
Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.
We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Chen(陈) Long, MD, PhD
- 전화번호: +8613883559467
- 이메일: neuroclong@126.com
연구 장소
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Chongqing
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Chongqing, Chongqing, 중국, 400014
- 모병
- Chen(陈)
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연락하다:
- Chen(陈) Long, MD,PhD
- 전화번호: +8613883559467
- 이메일: neuroclong@126.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Eligibility requirements for neonates:
- The gestational age is less than 32 weeks
- The preterm neonates are diagnosed with BPD and need invasive ventilation
- Extubation and subsequent noninvasive ventilation is ready to be carried out
Exclusion Criteria:
one of the following conditions is needed:
- there were no intraventricular hemorrhage(IVH) grades 3 or 4
- major congenital anomalies
- parents' decision not to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
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After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
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활성 비교기: NCPAP
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
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After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
re-intubation rate
기간: seven days after extubation
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the newborn infants with ventilated BPD is reintubated after extubation
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seven days after extubation
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death
기간: seven days after extubation
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the newborn infants with BPD die
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seven days after extubation
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the level of carbon dioxide
기간: seven days after extubation
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the level of carbon dioxide is measure after extubation between groups
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seven days after extubation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
necrotizing entercolitis(NEC)
기간: seven days after extubation
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the newborn infants with BPD is diagnosed with NEC
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seven days after extubation
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intraventricular hemorrhage(IVH)
기간: seven days after extubation
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the newborn infants with BPD is diagnosed with NEC
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seven days after extubation
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NHFOV for sBPD
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
기관지폐 이형성증에 대한 임상 시험
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Gaziosmanpasa Research and Education Hospital완전한2D 초음파 | Cavum Septum Pellucidum | Septooptic 이형성증 | 시신경교차 | 윌리스 폴리곤칠면조
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IRCCS National Neurological Institute "C. Mondino...모병
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Children's Hospital Los AngelesGenentech, Inc.완전한
NHFOV에 대한 임상 시험
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Daping Hospital and the Research Institute of Surgery...완전한
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Fondazione Poliambulanza Istituto OspedalieroFondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione IRCCS Ca' Granda... 그리고 다른 협력자들완전한
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Xingwang ZhuUniversity of Southern California; Children's Hospital of Fudan University; The Second Hospital... 그리고 다른 협력자들완전한
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Daping Hospital and the Research Institute of Surgery...모병
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Daping Hospital and the Research Institute of Surgery...The First Affiliated Hospital of Anhui Medical University; LanZhou University; Beijing 302... 그리고 다른 협력자들완전한