- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01326975
Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants
Effects of Continuous Positive Airway Pressure (CPAP) Delivered by High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on the Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants
연구 개요
상태
정황
상세 설명
Many preterm very low birth weight infants require continuous positive airway pressure(CPAP) for breathing support because of lung immaturity. CPAP can be delivered by the infant flow(TM) device which is well studied. Prolonged use of nasal prongs CPAP has been shown to cause discomfort and, rarely, nasal injury leading to long term disfigurement. On the other hand, High flow nasal cannula (HFNC) ,which is another modality of delivering CPAP, creates less pressure on the nose and less disfiguring effect but previous research showed that the use of HFNC may be less effective than IF-CPAP in providing breathing support in these infants.
We plan to study 10 stable preterm infants born less than 32 weeks' gestation and 1.5 kilograms at birth after being stable for at least 48hours on IF-CPAP. babies will be randomized to start on IF-CPAP or HFNC for 30 minutes. After 45 minutes of adaptation, baby will be switched to the other modality for another 30 minutes. By inserting a specialized feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi with each modality of delivering CPAP, we want to directly assess how HFNC affects breathing compared to IF-CPAP.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다
- Sunnybrook Health Sciences Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Birth weights ≤ 1500g
- Gestational age less than 32 week
- Stable on nasal continuous positive airway pressure (CPAP) of 5-6cmH20 support for at least 48 hours
- Treated with methylxanthines for apnea of prematurity
- In less than 35% oxygen
Exclusion Criteria:
- Congenital and acquired problem of the gastrointestinal tract
- Phrenic nerve injury and/or diaphragm paralysis
- Esophageal perforation/tracheoesophageal fistula
- Congenital/acquired neurological deficit and/or seizures
- Hemodynamic instability
- Congenital heart disease (including symptomatic patent ductus arteriosus)
- Undergoing treatment for sepsis or pneumonia
- Use of muscle relaxants, narcotic analgesics, or gastric motility agents
- Congenital anomalies of respiratory tract (e.g. CCAM)
- Infants requiring more than 35% oxygen
- Infants with facial anomalies
- Infants with pneumothorax and/or pneumomediatinum
- Infants in the immediate postoperative period
- Infants with significant gastric residues and vomiting
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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EAdi 1
babies in this group will first receive CPAP through IF-CPAP for 30 minutes.
After another 45 minutes, they will be switched to HFNC for 30 minutes.
EAdi will be recorded for the last 15 minutes of each 30 minutes period.
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EAdi 2
babies in this group will first receive CPAP through HFNC for 30 minutes.
After another 45 minutes, they will be switched to IF-CPAP for 30 minutes.
EAdi will be recorded for the last 15 minutes of each 30 minutes period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The difference in the tonic EAdi between IF-CPAP and HFNC .
기간: During the 4-hour study period.
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Patients will be randomized in two groups, one group will start on IF-CPAP for 30 minutes.
After another 45 minutes, this group will be switched to HFNC for another 30 minutes.
The other group will start on HFNC and then switched to IF-CPAP.
EAdi will be analyzed in the last 15 minutes of each 30 minutes period.
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During the 4-hour study period.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.
기간: During the 4-hour study period.
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During the 4-hour study period.
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Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.
기간: During the 4-hour study period.
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During the 4-hour study period.
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Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform.
기간: During the 4-hour study period.
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These indices include the phasic Edi to the peak, mean inspiratory Edi, Edi-time product, post inspiratory activity and all neural timings.
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During the 4-hour study period.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael Dunn, MD, Sunnybrook Health Sciences Centre
- 수석 연구원: Nehad Nasef, M.B.B.Ch, Sunnybrook Health Sciences Centre
- 수석 연구원: Maureen Reilly, RRT, Sunnybrook Health Sciences Centre
- 수석 연구원: Patti Schurr, RN(EC), Sunnybrook Health Sciences Centre
- 수석 연구원: Jennifer Beck, Ph.D., Unity Health Toronto
- 연구 책임자: Eugene Ng, MD, Sunnybrook Health Sciences Centre
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
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