Viewing Study NCT00067613



Ignite Creation Date: 2024-05-05 @ 11:30 AM
Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00067613
Status: COMPLETED
Last Update Posted: 2015-06-08
First Post: 2003-08-25

Brief Title: Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
Sponsor: NICHD Neonatal Research Network
Organization: NICHD Neonatal Research Network

Study Overview

Official Title: Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia to Reduce Bronchopulmonary Dysplasia
Status: COMPLETED
Status Verified Date: 2015-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Benchmarking
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 1250g 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
M01RR001032 NIH None httpsreporternihgovquickSearchM01RR001032
U10HD034216 NIH None None
U10HD021364 NIH None None
U10HD027853 NIH None None
U10HD027851 NIH None None
U01HD036790 NIH None None
U10HD027856 NIH None None
U10HD021397 NIH None None
U10HD027881 NIH None None
U10HD027880 NIH None None
U10HD021415 NIH None None
U10HD021373 NIH None None
U10HD021385 NIH None None
U10HD027871 NIH None None
U10HD034167 NIH None None
U10HD027904 NIH None None
M01RR008084 NIH None None
M01RR000750 NIH None None
M01RR000997 NIH None None
M01RR000070 NIH None None
M01RR006022 NIH None None
M01RR002635 NIH None None
M01RR002172 NIH None None