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Impact of a Physiologic Definition on Bronchopulmonary Dysplasia Rates

Bronchopulmonary dysplasia (BPD) is the endpoint of many intervention trials in neonatology, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. We previously reported a technique to standardize the...

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Published in:Pediatrics (Evanston) 2004-11, Vol.114 (5), p.1305-1311
Main Authors: Walsh, Michele C, Yao, Qing, Gettner, Patricia, Hale, Ellen, Collins, Monica, Hensman, Angelita, Everette, Ruth, Peters, Nancy, Miller, Nancy, Muran, Gerry, Auten, Kathy, Newman, Nancy, Rowan, Gina, Grisby, Cathy, Arnell, Kathy, Miller, Lucy, Ball, Bethany, McDavid, Georgia, National Institute of Child Health and Human Development Neonatal Research Network
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cited_by cdi_FETCH-LOGICAL-c605t-3c407097143eb2c8b894eab755a1b3f7c0c989af794e1f29614687b1392d4f2d3
cites cdi_FETCH-LOGICAL-c605t-3c407097143eb2c8b894eab755a1b3f7c0c989af794e1f29614687b1392d4f2d3
container_end_page 1311
container_issue 5
container_start_page 1305
container_title Pediatrics (Evanston)
container_volume 114
creator Walsh, Michele C
Yao, Qing
Gettner, Patricia
Hale, Ellen
Collins, Monica
Hensman, Angelita
Everette, Ruth
Peters, Nancy
Miller, Nancy
Muran, Gerry
Auten, Kathy
Newman, Nancy
Rowan, Gina
Grisby, Cathy
Arnell, Kathy
Miller, Lucy
Ball, Bethany
McDavid, Georgia
National Institute of Child Health and Human Development Neonatal Research Network
description Bronchopulmonary dysplasia (BPD) is the endpoint of many intervention trials in neonatology, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. We previously reported a technique to standardize the definition of BPD between sites by using a timed room-air challenge in selected infants. We hypothesized that a physiologic definition of BPD would reduce the variation in observed rates of BPD among different neonatal centers. Methodology. A total of 1598 consecutive inborn premature infants (501-1249 g birth weight) who remained hospitalized at 36 weeks' postmenstrual age were prospectively assessed and assigned an outcome with both a clinical definition and physiologic definition of BPD. The clinical definition of BPD was oxygen supplementation at exactly 36 weeks' postmenstrual age. The physiologic definition of BPD was assigned at 36 +/- 1 weeks' postmenstrual age and included 2 distinct subpopulations. First, neonates on positive pressure support or receiving >30% supplemental oxygen with saturations between 90% and 96% were assigned the outcome BPD and not tested further. Second, those receiving < or =30% oxygen or effective oxygen >30% with saturations >96% underwent a room-air challenge with continuous observation and oxygen-saturation monitoring. Outcomes of the room-air challenge were "no BPD" (saturations > or =90% during weaning and in room air for 30 minutes) or "BPD" (saturation
doi_str_mv 10.1542/peds.2004-0204
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We previously reported a technique to standardize the definition of BPD between sites by using a timed room-air challenge in selected infants. We hypothesized that a physiologic definition of BPD would reduce the variation in observed rates of BPD among different neonatal centers. Methodology. A total of 1598 consecutive inborn premature infants (501-1249 g birth weight) who remained hospitalized at 36 weeks' postmenstrual age were prospectively assessed and assigned an outcome with both a clinical definition and physiologic definition of BPD. The clinical definition of BPD was oxygen supplementation at exactly 36 weeks' postmenstrual age. The physiologic definition of BPD was assigned at 36 +/- 1 weeks' postmenstrual age and included 2 distinct subpopulations. First, neonates on positive pressure support or receiving &gt;30% supplemental oxygen with saturations between 90% and 96% were assigned the outcome BPD and not tested further. Second, those receiving &lt; or =30% oxygen or effective oxygen &gt;30% with saturations &gt;96% underwent a room-air challenge with continuous observation and oxygen-saturation monitoring. Outcomes of the room-air challenge were "no BPD" (saturations &gt; or =90% during weaning and in room air for 30 minutes) or "BPD" (saturation &lt;90%). At the conclusion of the room-air challenge, all infants were returned to their baseline oxygen levels. Safety (apnea, bradycardia, increased oxygen use) and outcomes of the physiologic definition versus the clinical definition were assessed. A total of 560 (35.0%) neonates were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks' postmenstrual age. The physiologic definition diagnosed BPD in 398 (25.0%) neonates in the cohort. All infants were safely studied. There were marked differences in the impact of the definition on BPD rates between centers (mean reduction: 10%; range: 0-44%). Sixteen centers had a decrease in their BPD rate, and 1 center had no change in their rate. The physiologic definition of BPD reduced the overall rate of BPD and reduced the variation among centers. Significant center differences in the impact of the physiologic definition were seen, and differences remained even with the use of this standardized definition. The magnitude of the change in BPD rate is comparable to the magnitude of treatment effects seen in some clinical trials in BPD. 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Second, those receiving &lt; or =30% oxygen or effective oxygen &gt;30% with saturations &gt;96% underwent a room-air challenge with continuous observation and oxygen-saturation monitoring. Outcomes of the room-air challenge were "no BPD" (saturations &gt; or =90% during weaning and in room air for 30 minutes) or "BPD" (saturation &lt;90%). At the conclusion of the room-air challenge, all infants were returned to their baseline oxygen levels. Safety (apnea, bradycardia, increased oxygen use) and outcomes of the physiologic definition versus the clinical definition were assessed. A total of 560 (35.0%) neonates were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks' postmenstrual age. The physiologic definition diagnosed BPD in 398 (25.0%) neonates in the cohort. All infants were safely studied. There were marked differences in the impact of the definition on BPD rates between centers (mean reduction: 10%; range: 0-44%). Sixteen centers had a decrease in their BPD rate, and 1 center had no change in their rate. The physiologic definition of BPD reduced the overall rate of BPD and reduced the variation among centers. Significant center differences in the impact of the physiologic definition were seen, and differences remained even with the use of this standardized definition. The magnitude of the change in BPD rate is comparable to the magnitude of treatment effects seen in some clinical trials in BPD. The physiologic definition of BPD facilitates the measurement of BPD as an outcome in clinical trials and the comparison between and within centers over time.</description><subject>Anatomy &amp; physiology</subject><subject>Apnea</subject><subject>Biological and medical sciences</subject><subject>Birth weight, Low</subject><subject>Bradycardia</subject><subject>Bronchopulmonary dysplasia</subject><subject>Bronchopulmonary Dysplasia - diagnosis</subject><subject>Bronchopulmonary Dysplasia - epidemiology</subject><subject>Bronchopulmonary Dysplasia - physiopathology</subject><subject>Bronchopulmonary Dysplasia - therapy</subject><subject>Care and treatment</subject><subject>Case studies</subject><subject>Diagnosis</subject><subject>Evaluation</subject><subject>General aspects</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Infant, Very Low Birth Weight</subject><subject>Low birth weight</subject><subject>Lungs</subject><subject>Medical sciences</subject><subject>Neonatal care</subject><subject>Neonatal intensive care</subject><subject>Observer Variation</subject><subject>Oxygen - blood</subject><subject>Oxygen Inhalation Therapy</subject><subject>Pediatrics</subject><subject>Pneumology</subject><subject>Premature birth</subject><subject>Respiratory diseases</subject><subject>Respiratory system : syndromes and miscellaneous diseases</subject><subject>Standardization</subject><issn>0031-4005</issn><issn>1098-4275</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><recordid>eNpt0tFr1DAcB_Aiijunrz5KERz40NsvadI0j_Pm5uBgIvoc0jTtZaRJTVr0_vul3MGcHCmkhM_v1_DrN8veI1gjSvDlqNu4xgCkAAzkRbZCwOuCYEZfZiuAEhUEgJ5lb2J8gMQow6-zM0QpBoTwKru5G0apptx3ucy_7_bReOt7o_Jr3RlnJuNdnp4vwTu18-NsB-9k2OfX-zhaGY3Mf8hJx7fZq07aqN8d9_Ps183Xn5tvxfb-9m5ztS1UBXQqSkWAAWeIlLrBqm5qTrRsGKUSNWXHFChec9mxdIw6zCtEqpo1qOS4JR1uy_Ps4tB3DP73rOMkBhOVtlY67ecoKgYlppQk-PE_-ODn4NLdBMY1AYqAJVQcUC-tFsZ1fgpS9drpIK13aQLp-Aphwnhqi5Jfn_BptXow6mTB52cFyUz679TLOUZR326f2-KUVd5a3WuRxri5P3kZFXyMQXdiDGZI_0YgEEs2xJINsWRDLNlIBR-OI5mbQbdP_BiGBD4dgYxK2i5Ip0x8chWmvOQ0ucuD25l-98cEvXzJyCkYFf95RYgIKlAJtHwEkJ7N2Q</recordid><startdate>20041101</startdate><enddate>20041101</enddate><creator>Walsh, Michele C</creator><creator>Yao, Qing</creator><creator>Gettner, Patricia</creator><creator>Hale, Ellen</creator><creator>Collins, Monica</creator><creator>Hensman, Angelita</creator><creator>Everette, Ruth</creator><creator>Peters, Nancy</creator><creator>Miller, Nancy</creator><creator>Muran, Gerry</creator><creator>Auten, Kathy</creator><creator>Newman, Nancy</creator><creator>Rowan, Gina</creator><creator>Grisby, Cathy</creator><creator>Arnell, Kathy</creator><creator>Miller, Lucy</creator><creator>Ball, Bethany</creator><creator>McDavid, Georgia</creator><creator>National Institute of Child Health and Human Development Neonatal Research Network</creator><general>Am Acad Pediatrics</general><general>American Academy of Pediatrics</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>8GL</scope><scope>7TS</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>U9A</scope><scope>7X8</scope></search><sort><creationdate>20041101</creationdate><title>Impact of a Physiologic Definition on Bronchopulmonary Dysplasia Rates</title><author>Walsh, Michele C ; Yao, Qing ; Gettner, Patricia ; Hale, Ellen ; Collins, Monica ; Hensman, Angelita ; Everette, Ruth ; Peters, Nancy ; Miller, Nancy ; Muran, Gerry ; Auten, Kathy ; Newman, Nancy ; Rowan, Gina ; Grisby, Cathy ; Arnell, Kathy ; Miller, Lucy ; Ball, Bethany ; McDavid, Georgia ; National Institute of Child Health and Human Development Neonatal Research Network</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c605t-3c407097143eb2c8b894eab755a1b3f7c0c989af794e1f29614687b1392d4f2d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Anatomy &amp; physiology</topic><topic>Apnea</topic><topic>Biological and medical sciences</topic><topic>Birth weight, Low</topic><topic>Bradycardia</topic><topic>Bronchopulmonary dysplasia</topic><topic>Bronchopulmonary Dysplasia - diagnosis</topic><topic>Bronchopulmonary Dysplasia - epidemiology</topic><topic>Bronchopulmonary Dysplasia - physiopathology</topic><topic>Bronchopulmonary Dysplasia - therapy</topic><topic>Care and treatment</topic><topic>Case studies</topic><topic>Diagnosis</topic><topic>Evaluation</topic><topic>General aspects</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infant, Premature</topic><topic>Infant, Very Low Birth Weight</topic><topic>Low birth weight</topic><topic>Lungs</topic><topic>Medical sciences</topic><topic>Neonatal care</topic><topic>Neonatal intensive care</topic><topic>Observer Variation</topic><topic>Oxygen - blood</topic><topic>Oxygen Inhalation Therapy</topic><topic>Pediatrics</topic><topic>Pneumology</topic><topic>Premature birth</topic><topic>Respiratory diseases</topic><topic>Respiratory system : syndromes and miscellaneous diseases</topic><topic>Standardization</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Walsh, Michele C</creatorcontrib><creatorcontrib>Yao, Qing</creatorcontrib><creatorcontrib>Gettner, Patricia</creatorcontrib><creatorcontrib>Hale, Ellen</creatorcontrib><creatorcontrib>Collins, Monica</creatorcontrib><creatorcontrib>Hensman, Angelita</creatorcontrib><creatorcontrib>Everette, Ruth</creatorcontrib><creatorcontrib>Peters, Nancy</creatorcontrib><creatorcontrib>Miller, Nancy</creatorcontrib><creatorcontrib>Muran, Gerry</creatorcontrib><creatorcontrib>Auten, Kathy</creatorcontrib><creatorcontrib>Newman, Nancy</creatorcontrib><creatorcontrib>Rowan, Gina</creatorcontrib><creatorcontrib>Grisby, Cathy</creatorcontrib><creatorcontrib>Arnell, Kathy</creatorcontrib><creatorcontrib>Miller, Lucy</creatorcontrib><creatorcontrib>Ball, Bethany</creatorcontrib><creatorcontrib>McDavid, Georgia</creatorcontrib><creatorcontrib>National Institute of Child Health and Human Development Neonatal Research Network</creatorcontrib><creatorcontrib>National Institute of Child Health and Human Development Neonatal Research Network</creatorcontrib><creatorcontrib>for the National Institute of Child Health and Human Development Neonatal Research Network</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: High School</collection><collection>Physical Education Index</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Pediatrics (Evanston)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Walsh, Michele C</au><au>Yao, Qing</au><au>Gettner, Patricia</au><au>Hale, Ellen</au><au>Collins, Monica</au><au>Hensman, Angelita</au><au>Everette, Ruth</au><au>Peters, Nancy</au><au>Miller, Nancy</au><au>Muran, Gerry</au><au>Auten, Kathy</au><au>Newman, Nancy</au><au>Rowan, Gina</au><au>Grisby, Cathy</au><au>Arnell, Kathy</au><au>Miller, Lucy</au><au>Ball, Bethany</au><au>McDavid, Georgia</au><au>National Institute of Child Health and Human Development Neonatal Research Network</au><aucorp>National Institute of Child Health and Human Development Neonatal Research Network</aucorp><aucorp>for the National Institute of Child Health and Human Development Neonatal Research Network</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of a Physiologic Definition on Bronchopulmonary Dysplasia Rates</atitle><jtitle>Pediatrics (Evanston)</jtitle><addtitle>Pediatrics</addtitle><date>2004-11-01</date><risdate>2004</risdate><volume>114</volume><issue>5</issue><spage>1305</spage><epage>1311</epage><pages>1305-1311</pages><issn>0031-4005</issn><eissn>1098-4275</eissn><coden>PEDIAU</coden><abstract>Bronchopulmonary dysplasia (BPD) is the endpoint of many intervention trials in neonatology, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. We previously reported a technique to standardize the definition of BPD between sites by using a timed room-air challenge in selected infants. We hypothesized that a physiologic definition of BPD would reduce the variation in observed rates of BPD among different neonatal centers. Methodology. A total of 1598 consecutive inborn premature infants (501-1249 g birth weight) who remained hospitalized at 36 weeks' postmenstrual age were prospectively assessed and assigned an outcome with both a clinical definition and physiologic definition of BPD. The clinical definition of BPD was oxygen supplementation at exactly 36 weeks' postmenstrual age. The physiologic definition of BPD was assigned at 36 +/- 1 weeks' postmenstrual age and included 2 distinct subpopulations. First, neonates on positive pressure support or receiving &gt;30% supplemental oxygen with saturations between 90% and 96% were assigned the outcome BPD and not tested further. Second, those receiving &lt; or =30% oxygen or effective oxygen &gt;30% with saturations &gt;96% underwent a room-air challenge with continuous observation and oxygen-saturation monitoring. Outcomes of the room-air challenge were "no BPD" (saturations &gt; or =90% during weaning and in room air for 30 minutes) or "BPD" (saturation &lt;90%). At the conclusion of the room-air challenge, all infants were returned to their baseline oxygen levels. Safety (apnea, bradycardia, increased oxygen use) and outcomes of the physiologic definition versus the clinical definition were assessed. A total of 560 (35.0%) neonates were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks' postmenstrual age. The physiologic definition diagnosed BPD in 398 (25.0%) neonates in the cohort. All infants were safely studied. There were marked differences in the impact of the definition on BPD rates between centers (mean reduction: 10%; range: 0-44%). Sixteen centers had a decrease in their BPD rate, and 1 center had no change in their rate. The physiologic definition of BPD reduced the overall rate of BPD and reduced the variation among centers. Significant center differences in the impact of the physiologic definition were seen, and differences remained even with the use of this standardized definition. The magnitude of the change in BPD rate is comparable to the magnitude of treatment effects seen in some clinical trials in BPD. The physiologic definition of BPD facilitates the measurement of BPD as an outcome in clinical trials and the comparison between and within centers over time.</abstract><cop>Elk Grove Village, IL</cop><pub>Am Acad Pediatrics</pub><pmid>15520112</pmid><doi>10.1542/peds.2004-0204</doi><tpages>7</tpages></addata></record>
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identifier ISSN: 0031-4005
ispartof Pediatrics (Evanston), 2004-11, Vol.114 (5), p.1305-1311
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1098-4275
language eng
recordid cdi_proquest_miscellaneous_67032554
source EZB Electronic Journals Library
subjects Anatomy & physiology
Apnea
Biological and medical sciences
Birth weight, Low
Bradycardia
Bronchopulmonary dysplasia
Bronchopulmonary Dysplasia - diagnosis
Bronchopulmonary Dysplasia - epidemiology
Bronchopulmonary Dysplasia - physiopathology
Bronchopulmonary Dysplasia - therapy
Care and treatment
Case studies
Diagnosis
Evaluation
General aspects
Humans
Infant, Newborn
Infant, Premature
Infant, Very Low Birth Weight
Low birth weight
Lungs
Medical sciences
Neonatal care
Neonatal intensive care
Observer Variation
Oxygen - blood
Oxygen Inhalation Therapy
Pediatrics
Pneumology
Premature birth
Respiratory diseases
Respiratory system : syndromes and miscellaneous diseases
Standardization
title Impact of a Physiologic Definition on Bronchopulmonary Dysplasia Rates
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