Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia to Reduce Bronchopulmonary Dysplasia

Conditions
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Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia (BPD)

Intervention / Treatment
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* Other: Benchmarking Management Practices
* Other: Standard Management Practices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Infants 501-1,249g birthweight Registered in a participating site Exclusion Criteria Diagnosed with a syndrome as defined by the Neonatal Research Network's Generic Database Study

Ages Eligible for Study
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Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites. | Other: Benchmarking Management Practices<br>* The Benchmarking intervention included: Data feedback: Using existing data from the NRN Generic Database and Key Care Practices Survey at their NICU to collect data on the perceptions of care. Training in Continuous Quality Improvement (CQI) Techniques Review of best existing evidence Site visits to the Centers with the Lowest Rates of BPD Selection of Practices to change: Each site team selected practices for modification at their own center<br>|
| Placebo Comparator: Control<br>Clinical sites randomized to Control will continue with their normal management practices for BPD. | Other: Standard Management Practices<br>* Centers assigned to the control group continued to receive routine information on their own center's outcomes, and all information routinely supplied within the NRN. Control centers did not participate in organized discussions of the interventions applied within the Benchmarking centers. At the completion of the study, Control Centers were offered a workshop on the Benchmarking techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without BPD |  | 36 weeks of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchopulmonary Dysplasia |  | 36 weeks of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Benchmarking, Chronic Lung Disease (CLD)