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Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia

N

NICHD Neonatal Research Network

Status

Completed

Conditions

Bronchopulmonary Dysplasia (BPD)
Infant, Low Birth Weight
Infant, Newborn
Infant, Small for Gestational Age
Infant, Premature

Treatments

Other: Benchmarking Management Practices
Other: Standard Management Practices

Study type

Interventional

Funder types

NETWORK
NIH

Identifiers

NCT00067613
U10HD034167 (U.S. NIH Grant/Contract)
M01RR006022 (U.S. NIH Grant/Contract)
U10HD021364 (U.S. NIH Grant/Contract)
U10HD027880 (U.S. NIH Grant/Contract)
U10HD027856 (U.S. NIH Grant/Contract)
U10HD027851 (U.S. NIH Grant/Contract)
M01RR001032 (U.S. NIH Grant/Contract)
M01RR008084 (U.S. NIH Grant/Contract)
U10HD027871 (U.S. NIH Grant/Contract)
M01RR000997 (U.S. NIH Grant/Contract)
U10HD021373 (U.S. NIH Grant/Contract)
U10HD021415 (U.S. NIH Grant/Contract)
U10HD027853 (U.S. NIH Grant/Contract)
M01RR000070 (U.S. NIH Grant/Contract)
M01RR002635 (U.S. NIH Grant/Contract)
NICHD-NRN-0025
M01RR002172 (U.S. NIH Grant/Contract)
M01RR000750 (U.S. NIH Grant/Contract)
U10HD027881 (U.S. NIH Grant/Contract)
U10HD021397 (U.S. NIH Grant/Contract)
U01HD036790 (U.S. NIH Grant/Contract)
U10HD034216 (U.S. NIH Grant/Contract)
U10HD021385 (U.S. NIH Grant/Contract)
U10HD027904 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,095 patients

Sex

All

Ages

Under 36 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4,095 participants in 2 patient groups, including a placebo group

Intervention
Active Comparator group
Description:
Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites.
Treatment:
Other: Benchmarking Management Practices
Control
Placebo Comparator group
Description:
Clinical sites randomized to Control will continue with their normal management practices for BPD.
Treatment:
Other: Standard Management Practices

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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