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Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia (Benchmarking)

Primary Purpose

Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Benchmarking Management Practices
Standard Management Practices
Sponsored by
NICHD Neonatal Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Benchmarking, Chronic Lung Disease (CLD)

Eligibility Criteria

undefined - 36 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Stanford University
  • University of California at San Diego
  • Yale University
  • University of Miami
  • Emory University
  • Indiana University
  • Wayne State University
  • University of Rochester
  • Wake Forest University
  • RTI International
  • Duke University
  • Cincinnati Children's Medical Center
  • Case Western Reserve University, Rainbow Babies and Children's Hospital
  • Brown University, Women & Infants Hospital of Rhode Island
  • University of Texas Southwestern Medical Center at Dallas
  • University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites.

Clinical sites randomized to Control will continue with their normal management practices for BPD.

Outcomes

Primary Outcome Measures

Survival without BPD

Secondary Outcome Measures

Bronchopulmonary Dysplasia

Full Information

First Posted
August 25, 2003
Last Updated
June 3, 2015
Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00067613
Brief Title
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
Acronym
Benchmarking
Official Title
Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia to Reduce Bronchopulmonary Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia (BPD)
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Benchmarking, Chronic Lung Disease (CLD)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4095 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Clinical sites randomized to Control will continue with their normal management practices for BPD.
Intervention Type
Other
Intervention Name(s)
Benchmarking Management Practices
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard Management Practices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival without BPD
Time Frame
36 weeks of life
Secondary Outcome Measure Information:
Title
Bronchopulmonary Dysplasia
Time Frame
36 weeks of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele C. Walsh, MD
Organizational Affiliation
Case Western Reserve University, Rainbow Babies & Children's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
William Oh, MD
Organizational Affiliation
Brown University, Women & Infants Hospital of Rhode Island
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waldemar A. Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahnaz Duara, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara J. Stoll, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James A. Lemons, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David K. Stevenson, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil N. Finer, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abbot R. Laptook, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seetha Shankaran, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward F. Donovan, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald N. Goldberg, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dale L. Phelps, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon E. Tyson, MD MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
T. Michael O'Shea, MD MPH
Organizational Affiliation
Wake Forest University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard A. Ehrenkranz, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
W. Kenneth Poole, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8774
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest University
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
RTI International
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University, Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Brown University, Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19651577
Citation
Bhandari V, Finer NN, Ehrenkranz RA, Saha S, Das A, Walsh MC, Engle WA, VanMeurs KP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Synchronized nasal intermittent positive-pressure ventilation and neonatal outcomes. Pediatrics. 2009 Aug;124(2):517-26. doi: 10.1542/peds.2008-1302. Epub 2009 Jul 27.
Results Reference
result
PubMed Identifier
16598294
Citation
Laptook AR, Salhab W, Allen J, Saha S, Walsh M. Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? J Perinatol. 2006 Jun;26(6):337-41. doi: 10.1038/sj.jp.7211500.
Results Reference
result
PubMed Identifier
17015558
Citation
Shankaran S, Langer JC, Kazzi SN, Laptook AR, Walsh M; National Institute of Child Health and Human Development Neonatal Research Network. Cumulative index of exposure to hypocarbia and hyperoxia as risk factors for periventricular leukomalacia in low birth weight infants. Pediatrics. 2006 Oct;118(4):1654-9. doi: 10.1542/peds.2005-2463.
Results Reference
result
PubMed Identifier
17473087
Citation
Walsh M, Laptook A, Kazzi SN, Engle WA, Yao Q, Rasmussen M, Buchter S, Heldt G, Rhine W, Higgins R, Poole K; National Institute of Child Health and Human Development Neonatal Research Network. A cluster-randomized trial of benchmarking and multimodal quality improvement to improve rates of survival free of bronchopulmonary dysplasia for infants with birth weights of less than 1250 grams. Pediatrics. 2007 May;119(5):876-90. doi: 10.1542/peds.2006-2656.
Results Reference
result
PubMed Identifier
16199694
Citation
Walsh M, Engle W, Laptook A, Kazzi SN, Buchter S, Rasmussen M, Yao Q; National Institute of Child Health and Human Development Neonatal Research Network. Oxygen delivery through nasal cannulae to preterm infants: can practice be improved? Pediatrics. 2005 Oct;116(4):857-61. doi: 10.1542/peds.2004-2411.
Results Reference
result
PubMed Identifier
19204058
Citation
Wilson-Costello D, Walsh MC, Langer JC, Guillet R, Laptook AR, Stoll BJ, Shankaran S, Finer NN, Van Meurs KP, Engle WA, Das A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Impact of postnatal corticosteroid use on neurodevelopment at 18 to 22 months' adjusted age: effects of dose, timing, and risk of bronchopulmonary dysplasia in extremely low birth weight infants. Pediatrics. 2009 Mar;123(3):e430-7. doi: 10.1542/peds.2008-1928. Epub 2009 Feb 9.
Results Reference
result
Links:
URL
http://neonatal.rti.org/
Description
NICHD Neonatal Research Network

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Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

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