Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

NCT00067613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4095

Last updated 2015-06-08

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Benchmarking Management Practices

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

OTHER

Standard Management Practices

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.

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH
  • NICHD Neonatal Research Network

    lead NETWORK

Principal Investigators

  • Michele C. Walsh, MD · Case Western Reserve University, Rainbow Babies & Children's Hospital

  • William Oh, MD · Brown University, Women & Infants Hospital of Rhode Island

  • Waldemar A. Carlo, MD · University of Alabama at Birmingham

  • Shahnaz Duara, MD · University of Miami

  • Barbara J. Stoll, MD · Emory University

  • James A. Lemons, MD · Indiana University

  • David K. Stevenson, MD · Stanford University

  • Neil N. Finer, MD · University of California, San Diego

  • Abbot R. Laptook, MD · University of Texas Southwestern Medical Center

  • Seetha Shankaran, MD · Wayne State University

  • Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

  • Ronald N. Goldberg, MD · Duke University

  • Dale L. Phelps, MD · University of Rochester

  • Jon E. Tyson, MD MPH · The University of Texas Health Science Center, Houston

  • T. Michael O'Shea, MD MPH · Wake Forest University

  • Richard A. Ehrenkranz, MD · Yale University

  • W. Kenneth Poole, PhD · RTI International

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2004-05-31
Completion
2004-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00067613 on ClinicalTrials.gov