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| Sponsored by: |
National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | 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 |
| 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 |
| Estimated Enrollment: | 8500 |
| Study Start Date: | March 2001 |
| Estimated Study Completion Date: | August 2004 |
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 |
Inclusion Criteria
Exclusion Criteria
Contacts and 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 | |||||
| Principal Investigator: | Michele Walsh-Sukys, MD | Case Western Reserve University |
More Information
Click here for more information about the Neonatal Research Network. 
  |
| Study ID Numbers: | 2U10HD021364 |
| First Received: | August 25, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00067613 |
| Health Authority: | United States: Federal Government |
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