- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00067613
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia (Benchmarking)
Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia to Reduce Bronchopulmonary Dysplasia
연구 개요
상태
상세 설명
In 1998, 55% of Very Low Birth Weight (VBLW) infants (those born at <1,250g) born at centers in the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) either died or developed BPD.
Previous studies within the NICHD Neonatal Research Network showed substantial differences in the incidence of BPD between centers. These differences were not explained by birth weight, gestational age, race, frequency of antenatal steroid use, or incidence of respiratory distress syndrome. Practice differences may contribute to BPD incidence variation. This study evaluated the efficacy of a Benchmarking Initiative to modify clinical care practices and decrease incidence of BPD in VLBW infants.
This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality improvement would change practices and improve rates of survival without BPD in inborn neonates with birth weights of <1250 grams. Benchmarking is a method involving detailed comparisons of processes between similar organizations. For this study, three NRN centers with the lowest rates of BPD have been identified as Benchmark centers. During a 6-month pre-intervention period, details of care practices and management style at these centers were carefully assessed. Based on practices at these Benchmarking sites, we developed a quality improvement program. For this study, 14 other NRN sites were randomized to either implement the benchmarking intervention (intervention sites) or continue with their usual care practices (control sites). After the 1-year intervention period, we compared changes in the rate of survival without BPD at 36 weeks corrected age between the intervention and control sites.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmingham
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California
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Palo Alto, California, 미국, 94304
- Stanford University
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San Diego, California, 미국, 92103-8774
- University of California at San Diego
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Connecticut
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New Haven, Connecticut, 미국, 06504
- Yale University
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Florida
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Miami, Florida, 미국, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, 미국, 30303
- Emory University
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University
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Michigan
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Detroit, Michigan, 미국, 48201
- Wayne State University
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New York
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Rochester, New York, 미국, 14642
- University of Rochester
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North Carolina
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Charlotte, North Carolina, 미국, 27157
- Wake Forest University
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Durham, North Carolina, 미국, 27710
- Duke University
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Durham, North Carolina, 미국, 27705
- RTI International
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Ohio
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Cincinnati, Ohio, 미국, 45267
- Cincinnati Children's Medical Center
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve University, Rainbow Babies and Children's Hospital
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Rhode Island
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Providence, Rhode Island, 미국, 02905
- Brown University, Women & Infants Hospital of Rhode Island
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Texas
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Dallas, Texas, 미국, 75235
- University of Texas Southwestern Medical Center at Dallas
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Houston, Texas, 미국, 77030
- University of Texas Health Science Center at Houston
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
- Infants 501-1,249g birthweight
- Registered in a participating site
Exclusion Criteria
- Diagnosed with a syndrome as defined by the Neonatal Research Network's Generic Database Study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Intervention
Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites.
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The Benchmarking intervention included:
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위약 비교기: Control
Clinical sites randomized to Control will continue with their normal management practices for BPD.
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Centers assigned to the control group continued to receive routine information on their own center's outcomes, and all information routinely supplied within the NRN.
Control centers did not participate in organized discussions of the interventions applied within the Benchmarking centers.
At the completion of the study, Control Centers were offered a workshop on the Benchmarking techniques.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Survival without BPD
기간: 36 weeks of life
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36 weeks of life
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2차 결과 측정
결과 측정 |
기간 |
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Bronchopulmonary Dysplasia
기간: 36 weeks of life
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36 weeks of life
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shahnaz Duara, MD, University of Miami
- 수석 연구원: Jon E. Tyson, MD MPH, The University of Texas Health Science Center, Houston
- 수석 연구원: Abbot R. Laptook, MD, University of Texas Southwestern Medical Center
- 연구 책임자: Michele C. Walsh, MD, Case Western Reserve University, Rainbow Babies & Children's Hospital
간행물 및 유용한 링크
일반 간행물
- Laptook AR, Salhab W, Allen J, Saha S, Walsh M. Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? J Perinatol. 2006 Jun;26(6):337-41. doi: 10.1038/sj.jp.7211500.
- Bhandari V, Finer NN, Ehrenkranz RA, Saha S, Das A, Walsh MC, Engle WA, VanMeurs KP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Synchronized nasal intermittent positive-pressure ventilation and neonatal outcomes. Pediatrics. 2009 Aug;124(2):517-26. doi: 10.1542/peds.2008-1302. Epub 2009 Jul 27.
- Shankaran S, Langer JC, Kazzi SN, Laptook AR, Walsh M; National Institute of Child Health and Human Development Neonatal Research Network. Cumulative index of exposure to hypocarbia and hyperoxia as risk factors for periventricular leukomalacia in low birth weight infants. Pediatrics. 2006 Oct;118(4):1654-9. doi: 10.1542/peds.2005-2463.
- Walsh M, Laptook A, Kazzi SN, Engle WA, Yao Q, Rasmussen M, Buchter S, Heldt G, Rhine W, Higgins R, Poole K; National Institute of Child Health and Human Development Neonatal Research Network. A cluster-randomized trial of benchmarking and multimodal quality improvement to improve rates of survival free of bronchopulmonary dysplasia for infants with birth weights of less than 1250 grams. Pediatrics. 2007 May;119(5):876-90. doi: 10.1542/peds.2006-2656.
- Walsh M, Engle W, Laptook A, Kazzi SN, Buchter S, Rasmussen M, Yao Q; National Institute of Child Health and Human Development Neonatal Research Network. Oxygen delivery through nasal cannulae to preterm infants: can practice be improved? Pediatrics. 2005 Oct;116(4):857-61. doi: 10.1542/peds.2004-2411.
- Wilson-Costello D, Walsh MC, Langer JC, Guillet R, Laptook AR, Stoll BJ, Shankaran S, Finer NN, Van Meurs KP, Engle WA, Das A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Impact of postnatal corticosteroid use on neurodevelopment at 18 to 22 months' adjusted age: effects of dose, timing, and risk of bronchopulmonary dysplasia in extremely low birth weight infants. Pediatrics. 2009 Mar;123(3):e430-7. doi: 10.1542/peds.2008-1928. Epub 2009 Feb 9.
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NICHD-NRN-0025
- U10HD021364 (미국 NIH 보조금/계약)
- U10HD021373 (미국 NIH 보조금/계약)
- U10HD021385 (미국 NIH 보조금/계약)
- U10HD027851 (미국 NIH 보조금/계약)
- U10HD027853 (미국 NIH 보조금/계약)
- U10HD027856 (미국 NIH 보조금/계약)
- U10HD027871 (미국 NIH 보조금/계약)
- U10HD027880 (미국 NIH 보조금/계약)
- U10HD027904 (미국 NIH 보조금/계약)
- U10HD034216 (미국 NIH 보조금/계약)
- U10HD021415 (미국 NIH 보조금/계약)
- U10HD027881 (미국 NIH 보조금/계약)
- M01RR008084 (미국 NIH 보조금/계약)
- M01RR006022 (미국 NIH 보조금/계약)
- M01RR000750 (미국 NIH 보조금/계약)
- M01RR000070 (미국 NIH 보조금/계약)
- M01RR000997 (미국 NIH 보조금/계약)
- U10HD021397 (미국 NIH 보조금/계약)
- U10HD034167 (미국 NIH 보조금/계약)
- M01RR001032 (미국 NIH 보조금/계약)
- M01RR002172 (미국 NIH 보조금/계약)
- M01RR002635 (미국 NIH 보조금/계약)
- U01HD036790 (미국 NIH 보조금/계약)
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 이형성증(BPD)에 대한 임상 시험
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Universitat Jaume IHospital de la Ribera아직 모집하지 않음
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Fundació Institut de Recerca de l'Hospital de la...모병
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University of OldenburgProf. René Hurlemann; Jella Voelter, M.Sc.모병
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University Hospital, Basel, SwitzerlandLeading House for the Latin American Region (Seed Money Grant SMG 1730)빼는경계선 성격 장애(BPD)
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NHS Greater Glasgow and Clyde알려지지 않은
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AbbVie모병건강한 자원봉사자 | 범불안 장애(GAD) | 양극성 장애(BPD)미국
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Gaziosmanpasa Research and Education Hospital완전한2D 초음파 | Cavum Septum Pellucidum | Septooptic 이형성증 | 시신경교차 | 윌리스 폴리곤칠면조
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Karolinska InstitutetThe Swedish Research Council; Göteborg University; University of California, San Francisco; Region Stockholm 그리고 다른 협력자들모집하지 않고 적극적으로
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ArkinAmsterdam UMC, location VUmc; Ziekenhuis Amstelland; Meander Medisch Centrum; Sinai Centrum... 그리고 다른 협력자들모병외상 후 스트레스 장애(PTSD) | 경계선 성격 장애(BPD)네덜란드
Benchmarking Management Practices에 대한 임상 시험
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University of California, Los Angeles모병
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Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention완전한
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Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention모병
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naomi goldsteinNational Institute of Mental Health (NIMH)완전한
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Parnassia Addiction Research CentreAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Leiden University Medical... 그리고 다른 협력자들아직 모집하지 않음대마초 사용 장애