Premature infants may develop bronchopulmonary dysplasia (BPD), a type of chronic lung disease. The type of care that a premature infant receives in a neonatal intensive care unit (NICU) may affect whether the infant will develop BPD. This study will compare care practices between different NICUs to see which practices prevent BPD. The study will then create, administer, and evaluate a program designed to improve care practices in NICUs.

Condition	Treatment or Intervention
Bronchopulmonary Dysplasia	Device: ventilation strategies  Drug: steroid therapy  Drug: surfactant therapy  Drug: drug strategies  Device: device strategies

Further Study Details: 

Expected Total Enrollment:  8500

Although survival of very low birth weight (VLBW, <1500 g) infants has improved, many of these infants sustain chronic lung injury that is a significant health burden. Previous studies within the NICHD Neonatal Research Network have shown 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 will evaluate the efficacy of a Benchmarking Initiative to modify clinical care practices and decrease incidence of BPD in VLBW infants.

Benchmarking is a method involving detailed comparisons of processes between similar organizations. For this study, three Network 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 three centers will be carefully assessed. The baseline rate of BPD at each center will be measured for a 1-year period using a physiologic definition of BPD designed for this study. This definition of BPD is based on a measurement of room air oxygen saturation.

After the pre-intervention period, 14 study sites within the Network will be randomized to either the benchmarking intervention or usual care practices. The benchmarking intervention will consist of data feedback, training in continuous quality improvement techniques, evidence review, site visits to the 3 benchmark centers, and identification of practice changes. The intervention will last 1 year. Change in rate of survival without BPD at 36 weeks corrected age will be compared between the intervention sites and the control sites. The rate of BPD at each site in the post-intervention period will also be compared to its pre-intervention rate.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Infants born at participating center
• Birthweight of 501 to 1249 grams (1.1 to 2.75 lbs.)

Exclusion Criteria

• Diagnosed with a syndrome as defined by the Neonatal Research Network’s Generic Database Study

Alabama
      University of Alabama, Birmingham,  Alabama,  United States
California
      Stanford University, Palo Alto,  California,  United States
      University of California at San Diego, San Diego,  California,  United States
Connecticut
      Yale University, New Haven,  Connecticut,  United States
Florida
      University of Miami, Miami,  Florida,  United States
Georgia
      Emory University, Atlanta,  Georgia,  United States
Indiana
      Indiana University, Indianapolis,  Indiana,  United States
Michigan
      Wayne State University, Detroit,  Michigan,  United States
New York
      University of Rochester, Rochester,  New York,  United States
North Carolina
      Duke University, Durham,  North Carolina,  United States
      Wake Forest University, Charlotte,  North Carolina,  United States
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  United States
      University of Cincinnati, Cincinnati,  Ohio,  United States
Rhode Island
      Women and Infants Hospital, Brown University, Providence,  Rhode Island,  United States
Texas
      University of Texas - Dallas, Dallas,  Texas,  United States
      University of Texas at Houston, Houston,  Texas,  United States

Study chairs or principal investigators

Michele Walsh-Sukys, MD,  Principal Investigator,  Case Western Reserve University   

Study ID Numbers:  2U10HD021364
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  August 25, 2003
ClinicalTrials.gov Identifier:  NCT00067613
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08