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| Descriptive Information Fields | |||||
| Brief Title † | Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia | ||||
| Official Title † | A Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Bronchopulmonary Dysplasia | ||||
| Intervention † | Device: ventilation strategies Drug: steroid therapy Drug: surfactant therapy Drug: drug strategies Device: device strategies |
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| MEDLINE PMIDs | |||||
| Links | Click here for more information about the Neonatal Research Network.  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 8500 | ||||
| Start Date † | March 2001 | ||||
| Completion Date | August 2004 | ||||
| Eligibility Criteria † | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00067613 | ||||
| Organization ID | 2U10HD021364 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | September 2004 | ||||
| First Received Date † | August 25, 2003 | ||||
| Last Updated Date | June 23, 2005 | ||||
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