Infant, Premature Clinical Trial
Official title:
Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia to Reduce Bronchopulmonary Dysplasia
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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