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Home > "B" Clinical Trials Conditions > Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia  Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
For Condition: Bronchopulmonary Dysplasia
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 8500
Location and Contact Information:
Overall Study Official:
MicheleWalsh-Sukys, Principal Investigator, Case Western Reserve University
Emory University *Recruiting*
Atlanta, Georgia,
United States
Recruiting Barbara Stoll 404-727-5740
University of Cincinnati *Recruiting*
Cincinnati, Ohio,
United States
Recruiting Edward Donovan 513-636-0182
Case Western Reserve University *Recruiting*
Cleveland, Ohio,
United States
Recruiting Michele Walsh-Sukys 216-844-3759
University of Miami *Recruiting*
Miami, Florida,
United States
Recruiting Shahnaz Duara 305-585-6408
University of Texas - Dallas *Recruiting*
Dallas, Texas,
United States
Recruiting Abbot Laptook 214-648-3753
Wake Forest University *Recruiting*
Charlotte, North Carolina,
United States
Recruiting T. O'Shea 336-716-6097
Yale University *Recruiting*
New Haven, Connecticut,
United States
Recruiting Richard Ehrenkranz 203-688-2895
University of Alabama *Recruiting*
Birmingham, Alabama,
United States
Recruiting Waldemar Carlo 205-934-4680
Wayne State University *Recruiting*
Detroit, Michigan,
United States
Recruiting Seetha Shankaran 313-745-1436
University of Texas at Houston *Recruiting*
Houston, Texas,
United States
Recruiting Jon Tyson 713-500-5651
University of California at San Diego *Recruiting*
San Diego, California,
United States
Recruiting Neil Finer 619-543-3759
Women and Infants Hospital, Brown University *Recruiting*
Providence, Rhode Island,
United States
Recruiting William Oh 401-444-5648
Indiana University *Recruiting*
Indianapolis, Indiana,
United States
Recruiting James Lemons 317-274-4716
Duke University *Recruiting*
Durham, North Carolina,
United States
Recruiting Ronald Goldberg 919-681-6025
Stanford University *Recruiting*
Palo Alto, California,
United States
Recruiting David Stevenson 650-723-5711
University of Rochester *Recruiting*
Rochester, New York,
United States
Recruiting Dale Phelps 585-275-2972
Additional Information:
Study ID Numbers: 2U10HD021364;
Study Start Date: March 2001
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067613
Other Bronchopulmonary Dysplasia Studies:
1. Inhaled NO in Prevention of Chronic Lung Disease
2. Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
3. Clinical Interventions in Respiratory Distress Syndrome and Neonatal Lung Injury - SCOR in Lung Biology and Diseases in Infants and Children
4. Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
5. Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia
Related Studies:
Other Bronchopulmonary Dysplasia Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
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