- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01526226
Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)
Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked.
The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort.
The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations.
The investigators plan to recruit 20 patients.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tromsø, 노르웨이, N-9038
- University Hospital of North Norway
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study)
- Gestational age (GA) < 34 weeks
- Corrected age < 34 weeks
- Receiving nasal CPAP for respiratory distress
- Respiratory "stable": FiO2 < 30%, pCO2 < 8,5 kPa and pH > 7.25.
- GA < 29 weeks: Respiratory "stable" over last 72 h.
- GA 29-33 weeks: Respiratory "stable" over last 24 h.
Exclusion Criteria:
- Congenital anomalies
- Ongoing treatment for hypoglycemia or infection
- Other intercurrent disease requiring frequent blood sampling
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HFNC
High flow nasal cannula
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In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
다른 이름들:
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
다른 이름들:
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활성 비교기: nCPAP
Nasal CPAP
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In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
다른 이름들:
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient comfort (EDIN score)
기간: 48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
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EDIN score (neonatal pain and comfort score) is a validated scoring system to assess pain and comfort in term and preterm infants.
The cumulative EDIN score, based on three evaluations/24 h, is recorded for each 24 h epoch with HFNC or CPAP, respectively.
The change in EDIN score between the two 24 h epochs are assessed.
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48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Noise
기간: Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Surrounding noise (dB)is measured twice daily during the 2 x 24 (48) h study period; twice during CPAP and twice during HFNC.
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Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Parental satisfaction
기간: Three questions answered after 24 h and 48 h
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3 questions related to parental satisfaction are asked by the end of each 24 h epoch with either CPAP or HFNC.
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Three questions answered after 24 h and 48 h
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Stress hormone response (salivary cortisol)
기간: Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Salivary cortisol is used as a marker of stress hormone response.
Salivary cortisol is collected twice (10 AM and 10 PM) for every 24 h epoch; a total of 4 measurements.
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Measured at 10 AM and 10 PM over 48 h (4 measurements)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Claus Klingenberg, MD, PhD, University Hospital of North Norway, Tromsø, Norway
간행물 및 유용한 링크
일반 간행물
- Wilkinson D, Andersen C, O'Donnell CP, De Paoli AG. High flow nasal cannula for respiratory support in preterm infants. Cochrane Database Syst Rev. 2011 May 11;(5):CD006405. doi: 10.1002/14651858.CD006405.pub2.
- Klingenberg C, Pettersen M, Hansen EA, Gustavsen LJ, Dahl IA, Leknessund A, Kaaresen PI, Nordhov M. Patient comfort during treatment with heated humidified high flow nasal cannulae versus nasal continuous positive airway pressure: a randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F134-7. doi: 10.1136/archdischild-2013-304525. Epub 2013 Nov 13.
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2011-2019 REK NORD
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