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Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia (Benchmarking)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00067613
Recruitment Status : Completed
First Posted : August 26, 2003
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia (BPD) Other: Benchmarking Management Practices Other: Standard Management Practices Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4095 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia to Reduce Bronchopulmonary Dysplasia
Study Start Date : March 2001
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention
Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites.
Other: 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

Placebo Comparator: Control
Clinical sites randomized to Control will continue with their normal management practices for BPD.
Other: 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.




Primary Outcome Measures :
  1. Survival without BPD [ Time Frame: 36 weeks of life ]

Secondary Outcome Measures :
  1. Bronchopulmonary Dysplasia [ Time Frame: 36 weeks of life ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067613


Locations
Show Show 17 study locations
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Investigators
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Study Director: Michele C. Walsh, MD Case Western Reserve University, Rainbow Babies & Children's Hospital
Principal Investigator: William Oh, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: Shahnaz Duara, MD University of Miami
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: James A. Lemons, MD Indiana University
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: Neil N. Finer, MD University of California, San Diego
Principal Investigator: Abbot R. Laptook, MD University of Texas Southwestern Medical Center
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Ronald N. Goldberg, MD Duke University
Principal Investigator: Dale L. Phelps, MD University of Rochester
Principal Investigator: Jon E. Tyson, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: T. Michael O'Shea, MD MPH Wake Forest University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: W. Kenneth Poole, PhD RTI International
Additional Information:
Publications of Results:

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Responsible Party: Michele C. Walsh, Lead Principal Investigator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00067613    
Other Study ID Numbers: NICHD-NRN-0025
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U01HD036790 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U10HD027881 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD034167 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
M01RR002635 ( U.S. NIH Grant/Contract )
M01RR002172 ( U.S. NIH Grant/Contract )
M01RR001032 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2003    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Very Low Birth Weight (VLBW)
Prematurity
Mechanical ventilation
Benchmarking
Chronic Lung Disease (CLD)
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Hyperplasia
Birth Weight
Pathologic Processes
Body Weight
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases