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Completed

NCT Number: NCT00067613

Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

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.

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Key information

Conditions

Infant, Newborn Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia (BPD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Low Birth Weight Infant, Newborn, Diseases Infant, Premature Infant, Premature, Diseases Infant, Small for Gestational Age Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benchmarking Management Practices

Other

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

Standard Management Practices

Other

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 outcomes

  1. Survival without BPD

    Time frame: 36 weeks of life

Secondary outcomes

  1. Bronchopulmonary Dysplasia

    Time frame: 36 weeks of life

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

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

Acronym: Benchmarking

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Aug 26, 2003
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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