Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia (Benchmarking)
3. juni 2015 opdateret af: NICHD Neonatal Research Network
Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4095
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham
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California
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Palo Alto, California, Forenede Stater, 94304
- Stanford University
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San Diego, California, Forenede Stater, 92103-8774
- University of California at San Diego
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06504
- Yale University
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Emory University
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 27157
- Wake Forest University
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Durham, North Carolina, Forenede Stater, 27710
- Duke University
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Durham, North Carolina, Forenede Stater, 27705
- RTI International
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45267
- Cincinnati Children's Medical Center
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Cleveland, Ohio, Forenede Stater, 44106
- Case Western Reserve University, Rainbow Babies and Children's Hospital
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02905
- Brown University, Women & Infants Hospital of Rhode Island
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Texas
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Dallas, Texas, Forenede Stater, 75235
- University of Texas Southwestern Medical Center at Dallas
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Houston, Texas, Forenede Stater, 77030
- University of Texas Health Science Center at Houston
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 8 måneder (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Intervention
Clinical sites randomized to intervention will receive training in the benchmarking BPD management methods identified at the Benchmark sites.
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The Benchmarking intervention included:
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Placebo komparator: Control
Clinical sites randomized to Control will continue with their normal management practices for BPD.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Survival without BPD
Tidsramme: 36 weeks of life
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36 weeks of life
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Bronchopulmonary Dysplasia
Tidsramme: 36 weeks of life
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36 weeks of life
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Shahnaz Duara, MD, University of Miami
- Ledende efterforsker: Jon E. Tyson, MD MPH, The University of Texas Health Science Center, Houston
- Ledende efterforsker: Abbot R. Laptook, MD, University of Texas Southwestern Medical Center
- Studieleder: Michele C. Walsh, MD, Case Western Reserve University, Rainbow Babies & Children's Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2001
Primær færdiggørelse (Faktiske)
1. maj 2004
Studieafslutning (Faktiske)
1. maj 2004
Datoer for studieregistrering
Først indsendt
25. august 2003
Først indsendt, der opfyldte QC-kriterier
25. august 2003
Først opslået (Skøn)
26. august 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NICHD-NRN-0025
- U10HD021364 (U.S. NIH-bevilling/kontrakt)
- U10HD021373 (U.S. NIH-bevilling/kontrakt)
- U10HD021385 (U.S. NIH-bevilling/kontrakt)
- U10HD027851 (U.S. NIH-bevilling/kontrakt)
- U10HD027853 (U.S. NIH-bevilling/kontrakt)
- U10HD027856 (U.S. NIH-bevilling/kontrakt)
- U10HD027871 (U.S. NIH-bevilling/kontrakt)
- U10HD027880 (U.S. NIH-bevilling/kontrakt)
- U10HD027904 (U.S. NIH-bevilling/kontrakt)
- U10HD034216 (U.S. NIH-bevilling/kontrakt)
- U10HD021415 (U.S. NIH-bevilling/kontrakt)
- U10HD027881 (U.S. NIH-bevilling/kontrakt)
- M01RR008084 (U.S. NIH-bevilling/kontrakt)
- M01RR006022 (U.S. NIH-bevilling/kontrakt)
- M01RR000750 (U.S. NIH-bevilling/kontrakt)
- M01RR000070 (U.S. NIH-bevilling/kontrakt)
- M01RR000997 (U.S. NIH-bevilling/kontrakt)
- U10HD021397 (U.S. NIH-bevilling/kontrakt)
- U10HD034167 (U.S. NIH-bevilling/kontrakt)
- M01RR001032 (U.S. NIH-bevilling/kontrakt)
- M01RR002172 (U.S. NIH-bevilling/kontrakt)
- M01RR002635 (U.S. NIH-bevilling/kontrakt)
- U01HD036790 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .