- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01229384
Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions (BPAP)
Hypothesis: That administration of nebulized therapy for bronchiolitis when using positive airway pressure is superior to standard mask ventilation in reducing hospital admissions.
Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by a variety of different viruses. It is the most common LRTI in children under 24 months old. Multiple studies have documented variation in treatment, hospitalization rates, and length of hospital stay for bronchiolitis, suggesting a lack of consensus and an opportunity to improve care for this common disorder.
Research to determine optimal delivery methods of respiratory medications that may augment oxygenation by decreasing atelectasis (Lung cell collapse) and increasing oxygen saturation have not been done. Currently bronchodilators are delivered through a passive process, inhaled as they are nebulized (made from liquid into gas) into a face mask. This study will evaluate whether using a newly developed positive pressure nebulization device that uses pressure to expand lung cells and, hypothetically, deliver the medication better, improves oxygenation by reducing atelectasis (lung cell collapse) to decrease hospitalization in infants with moderate to severe bronchiolitis.
Positive pressure nebulization is a relatively new adaptation of a previously existing modality, and is already currently in use here at PCH.
연구 개요
상태
정황
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Zebulon J Timmons, MD
- 전화번호: 402-203-9303
- 이메일: ztimmons@phoenixchildrens.com
연구 연락처 백업
- 이름: Mark Hostetler, MD
- 전화번호: 602-546-1910
- 이메일: mhostetler@phoenixchildrens.com
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85016
- 모병
- Phoenix Children's Hospital
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연락하다:
- Lara Hale, BA
- 전화번호: 602-546-1910
- 이메일: lhale@phoenixchildrens.com
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연락하다:
- David Bank, MD
- 전화번호: 602-546-1910
- 이메일: dbank@phoenixchildrens.com
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수석 연구원:
- Zebulon J Timmons, BA, MD
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부수사관:
- Mark Hostetler, MD
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부수사관:
- David Bank, MD
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부수사관:
- Dawn Barcellona, MD
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부수사관:
- Blake Bulloch, MD
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부수사관:
- Tom McConahay, MD
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부수사관:
- Rustin Morse, MD
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부수사관:
- Theresa Murdock, MD
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부수사관:
- Anthony Pickett, MD
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부수사관:
- Tamara Pottker, MD
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부수사관:
- Chris Ramsook, MD
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부수사관:
- Lalitha Ravi, MD
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부수사관:
- Karen Scharlatt, DO
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부수사관:
- Kopal Seth, MD
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부수사관:
- Robert Yniguez, MD
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부수사관:
- Stephanie Zimmerman, MD
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부수사관:
- Ming Chien, MD
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부수사관:
- Angelique Ferayorni, DO
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부수사관:
- Amanda Kasem, MD
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부수사관:
- William Schneider, DO
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부수사관:
- Karem Collindres-Duque, DO
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부수사관:
- Amanda Queen, PA
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부수사관:
- Lisa Keller, NP
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부수사관:
- Jessica Snow, NP
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부수사관:
- Carol Thrall, NP
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부수사관:
- Becky Brown, NP
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부수사관:
- Scharon Schaeffer, NP
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부수사관:
- Candy Schmitz, NP
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Infants 2-24 months with moderate to severe bronchiolitis
Exclusion Criteria:
- Those outside the age range of 2-24 months, or less than postconceptual age of 48weeks for premature infants
- Those with comorbid conditions such as cyanotic heart disease, home oxygen use, tracheostomy use, or other serious medical conditions.
- Those with history of apnea
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Positive Airway Pressure Nebulization
Will administer nebulized medications using Positive Airway Pressure Nebulization
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Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
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활성 비교기: Standard Nebulization
Current standard of administering nebulized medications without positive airway pressure
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Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Hospitalization Rates
기간: 2 weeks
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Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
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2 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in bronchiolitis Score
기간: day of presentation
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Will measure change in bronchiolitis score by repiratory therapy of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
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day of presentation
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Change in Oxygen Saturation
기간: Day of presentation
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Will measure change in oxygen saturation of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
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Day of presentation
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Intensive Care Unit Admission Rate
기간: day of presentation
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Will measure rate of hospitalization in the intensive care unit of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
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day of presentation
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Length of Stay
기간: To be determined
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Will measure length of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
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To be determined
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Unscheduled Return to the Emergency Department
기간: 2 weeks
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Will measure rate of unscheduled return to the ED of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.
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2 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Zebulon J Timmons, MD, Phoenix Children's Hospital
- 연구 책임자: Mark Hostetler, MD, Phoenix Children's Hospital
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. .
Positive Airway Pressure nebulization에 대한 임상 시험
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