Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia (Benchmarking)
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| ClinicalTrials.gov Identifier: NCT00067613 |
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Recruitment Status :
Completed
First Posted : August 26, 2003
Last Update Posted : June 8, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia (BPD) | Other: Benchmarking Management Practices Other: Standard Management Practices | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4095 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia to Reduce Bronchopulmonary Dysplasia |
| Study Start Date : | March 2001 |
| Actual Primary Completion Date : | May 2004 |
| Actual Study Completion Date : | May 2004 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Intervention
Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites.
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Other: Benchmarking Management Practices
The Benchmarking intervention included:
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Placebo Comparator: Control
Clinical sites randomized to Control will continue with their normal management practices for BPD.
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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. |
- Survival without BPD [ Time Frame: 36 weeks of life ]
- Bronchopulmonary Dysplasia [ Time Frame: 36 weeks of life ]
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| Ages Eligible for Study: | up to 36 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067613
Show 17 study locations
| Study Director: | Michele C. Walsh, MD | Case Western Reserve University, Rainbow Babies & Children's Hospital | |
| Principal Investigator: | William Oh, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Shahnaz Duara, MD | University of Miami | |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
| Principal Investigator: | James A. Lemons, MD | Indiana University | |
| Principal Investigator: | David K. Stevenson, MD | Stanford University | |
| Principal Investigator: | Neil N. Finer, MD | University of California, San Diego | |
| Principal Investigator: | Abbot R. Laptook, MD | University of Texas Southwestern Medical Center | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Ronald N. Goldberg, MD | Duke University | |
| Principal Investigator: | Dale L. Phelps, MD | University of Rochester | |
| Principal Investigator: | Jon E. Tyson, MD MPH | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | T. Michael O'Shea, MD MPH | Wake Forest University | |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University | |
| Principal Investigator: | W. Kenneth Poole, PhD | RTI International |
Publications of Results:
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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) |
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Bronchopulmonary Dysplasia Birth Weight Body Weight Ventilator-Induced Lung Injury Lung Injury |
Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |