Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
NCT ID: NCT00067613
Last Updated: 2015-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4095 participants
INTERVENTIONAL
2001-03-31
2004-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites.
Benchmarking Management Practices
The Benchmarking intervention included:
1. Data feedback: Using existing data from the NRN Generic Database and Key Care Practices Survey at their NICU to collect data on the perceptions of care.
2. Training in Continuous Quality Improvement (CQI) Techniques
3. Review of best existing evidence
4. Site visits to the Centers with the Lowest Rates of BPD
5. Selection of Practices to change: Each site team selected practices for modification at their own center
Control
Clinical sites randomized to Control will continue with their normal management practices for BPD.
Standard Management Practices
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.
Interventions
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Benchmarking Management Practices
The Benchmarking intervention included:
1. Data feedback: Using existing data from the NRN Generic Database and Key Care Practices Survey at their NICU to collect data on the perceptions of care.
2. Training in Continuous Quality Improvement (CQI) Techniques
3. Review of best existing evidence
4. Site visits to the Centers with the Lowest Rates of BPD
5. Selection of Practices to change: Each site team selected practices for modification at their own center
Standard Management Practices
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.
Eligibility Criteria
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Inclusion Criteria
* Registered in a participating site
Exclusion Criteria
36 Weeks
ALL
Yes
Sponsors
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National Center for Research Resources (NCRR)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Case Western Reserve University
Principal Investigators
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Michele C. Walsh, MD
Role: STUDY_DIRECTOR
Case Western Reserve University, Rainbow Babies & Children's Hospital
William Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Waldemar A. Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Shahnaz Duara, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Barbara J. Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
James A. Lemons, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
David K. Stevenson, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Neil N. Finer, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Abbot R. Laptook, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Edward F. Donovan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Ronald N. Goldberg, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Dale L. Phelps, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Jon E. Tyson, MD MPH
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
T. Michael O'Shea, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University
Richard A. Ehrenkranz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
W. Kenneth Poole, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
University of California at San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Wayne State University
Detroit, Michigan, United States
University of Rochester
Rochester, New York, United States
Wake Forest University
Charlotte, North Carolina, United States
RTI International
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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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.
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.
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.
Related Links
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NICHD Neonatal Research Network
Other Identifiers
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NICHD-NRN-0025
Identifier Type: -
Identifier Source: org_study_id
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