CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,095 enrolled
Drug / intervention
Benchmarking Management Practices +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00067613
NCT00067613N/ACompleted

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

NICHD Neonatal Research Network·interventional·Posted Aug 26, 2003·Updated Jun 8, 2015

In Brief

A clinical study evaluating Benchmarking Management Practices and Standard Management Practices for Infant, Newborn and 4 related conditions. Completed, enrolled 4,095 participants across 17 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2003
Enrollment StartMar 1, 2001
Primary CompletionMay 1, 2004
TodayJul 1, 2026
Enrollment to primary: 3.2 yearsPosted 22.8 years ago

Interventions

Benchmarking Management Practicesother

The Benchmarking intervention included: 1. 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. 2. Training in Continuous Quality Improvement (CQI) Techniques 3. Review of best existing evidence 4. Site visits to the Centers with the Lowest Rates of BPD 5. Selection of Practices to change: Each site team selected practices for modification at their own center

Standard Management Practicesother

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.