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Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

This study is ongoing, but not recruiting participants.

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00067613
  Purpose

Premature infants may develop bronchopulmonary dysplasia (BPD), a type of chronic lung disease. The type of care that a premature infant receives in a neonatal intensive care unit (NICU) may affect whether the infant will develop BPD. This study will compare care practices between different NICUs to see which practices prevent BPD. The study will then create, administer, and evaluate a program designed to improve care practices in NICUs.


Condition Intervention
Bronchopulmonary Dysplasia
Device: ventilation strategies
Drug: steroid therapy
Drug: surfactant therapy
Drug: drug strategies
Device: device strategies

MedlinePlus related topics:   Premature Babies   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   A Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:   8500
Study Start Date:   March 2001
Estimated Study Completion Date:   August 2004

Detailed Description:

Although survival of very low birth weight (VLBW, <1500 g) infants has improved, many of these infants sustain chronic lung injury that is a significant health burden. Previous studies within the NICHD Neonatal Research Network have shown 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 will evaluate the efficacy of a Benchmarking Initiative to modify clinical care practices and decrease incidence of BPD in VLBW infants.

Benchmarking is a method involving detailed comparisons of processes between similar organizations. For this study, three Network 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 three centers will be carefully assessed. The baseline rate of BPD at each center will be measured for a 1-year period using a physiologic definition of BPD designed for this study. This definition of BPD is based on a measurement of room air oxygen saturation.

After the pre-intervention period, 14 study sites within the Network will be randomized to either the benchmarking intervention or usual care practices. The benchmarking intervention will consist of data feedback, training in continuous quality improvement techniques, evidence review, site visits to the 3 benchmark centers, and identification of practice changes. The intervention will last 1 year. Change in rate of survival without BPD at 36 weeks corrected age will be compared between the intervention sites and the control sites. The rate of BPD at each site in the post-intervention period will also be compared to its pre-intervention rate.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

  • Infants born at participating center
  • Birthweight of 501 to 1249 grams (1.1 to 2.75 lbs.)

Exclusion Criteria

  • Diagnosed with a syndrome as defined by the Neonatal Research Network’s Generic Database Study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067613

Locations
United States, Alabama
University of Alabama    
      Birmingham, Alabama, United States
United States, California
Stanford University    
      Palo Alto, California, United States
University of California at San Diego    
      San Diego, California, United States
United States, Connecticut
Yale University    
      New Haven, Connecticut, United States
United States, Florida
University of Miami    
      Miami, Florida, United States
United States, Georgia
Emory University    
      Atlanta, Georgia, United States
United States, Indiana
Indiana University    
      Indianapolis, Indiana, United States
United States, Michigan
Wayne State University    
      Detroit, Michigan, United States
United States, New York
University of Rochester    
      Rochester, New York, United States
United States, North Carolina
Duke University    
      Durham, North Carolina, United States
Wake Forest University    
      Charlotte, North Carolina, United States
United States, Ohio
Case Western Reserve University    
      Cleveland, Ohio, United States
University of Cincinnati    
      Cincinnati, Ohio, United States
United States, Rhode Island
Women and Infants Hospital, Brown University    
      Providence, Rhode Island, United States
United States, Texas
University of Texas - Dallas    
      Dallas, Texas, United States
University of Texas at Houston    
      Houston, Texas, United States

Sponsors and Collaborators

Investigators
Principal Investigator:     Michele Walsh-Sukys, MD     Case Western Reserve University    
  More Information


Click here for more information about the Neonatal Research Network.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   2U10HD021364
First Received:   August 25, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00067613
Health Authority:   United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Chronic lung disease  
Premature infant  
Benchmarking  

Study placed in the following topic categories:
Bronchopulmonary dysplasia
Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Lung Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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