Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial
CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days...
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creator | Curley, Martha A. Q Hibberd, Patricia L Fineman, Lori D Wypij, David Shih, Mei-Chiung Thompson, John E Grant, Mary Jo C Barr, Frederick E Cvijanovich, Natalie Z Sorce, Lauren Luckett, Peter M Matthay, Michael A Arnold, John H |
description | CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe
and to improve oxygenation in pediatric patients with acute lung injury. However,
the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days infants and children
with acute lung injury treated with prone positioning would have more ventilator-free
days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS Multicenter, randomized, controlled clinical trial conducted from August
28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric
intensive care units aged 2 weeks to 18 years who were treated with supine
vs prone positioning. Randomization was concealed and group assignment was
not blinded. INTERVENTION Patients were randomized to either supine or prone positioning within
48 hours of meeting acute lung injury criteria, with those patients in the
prone group being positioned within 4 hours of randomization and remaining
prone for 20 hours each day during the acute phase of their illness for a
maximum of 7 days, after which they were positioned supine. Both groups were
treated using lung protective ventilator and sedation protocols, extubation
readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE Ventilator-free days to day 28. RESULTS The trial was stopped at the planned interim analysis on the basis of
the prespecified futility stopping rule. There were no differences in the
number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5]
supine vs 15.6 [8.6] prone; mean difference, −0.2 days; 95% CI, −3.6
to 3.2; P = .91). After controlling for
age, Pediatric Risk of Mortality III score, direct vs indirect acute lung
injury, and mode of mechanical ventilation at enrollment, the adjusted difference
in ventilator-free days was 0.3 days (95% CI, −3.0 to 3.5; P = .87). There were no differences in the secondary end
points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P>.99), the time to recovery of lung injury (P = .78),
organ-failure−free days (P = .88),
and cognitive impairment (P = .16) or overall
functional health (P = .12) at hospital
discharge or on day 28. CONCLUSION Prone positioning does not significantly reduce ventilator-free days
or improve other clinical outcomes in pediatric patients with acute lung injury. |
doi_str_mv | 10.1001/jama.294.2.229 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_1237036</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ama_id>201187</ama_id><sourcerecordid>867908461</sourcerecordid><originalsourceid>FETCH-LOGICAL-a339t-fbd4d500553e123ad59b2cd8cd839c3614505a2aa7e1d62e36631f2491fe90643</originalsourceid><addsrcrecordid>eNpdkdFrFDEQxoMo9qy-Cr5IKOjbnplks7vxoXAcVQsHLVLxcZlLsr0c2aQmu0L96430LG1DICHzmy_fzBDyFtgSGINPexxxyVW95EvO1TOyACm6SkjVPScLxlRXtXVXH5FXOe9ZWSDal-QIGga1VO2CpLNhsHqicaCXKQZLL2N2k4vBhWsaA117F5xGTy_mScfRZurK4855k2ygP920oys9T5Zu5pJwHvZzuv1MV_Q7BhNH98cauo5hStH7cr1KDv1r8mJAn-2bw3lMfnw5u1p_qzYXX8_Xq02FQqipGramNpIxKYUFLtBIteXadGULpUVTCmASOWJrwTTciqYRMPBawWAVa2pxTE7vdG_m7WiNtsUG-v4muRHTbR_R9Y8jwe366_i7L7-1TDRF4ONBIMVfs81TP7qsrfcYbJxz33RMQGlxAU-egPs4p1CK6zmUjqsO2gK9f2jn3sf_WRTgwwHAXDo-JAza5Qec4krCP1vv7rgy-vsoZwBdK_4C_iihEw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>211379817</pqid></control><display><type>article</type><title>Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial</title><source>MEDLINE</source><source>American Medical Association Journals</source><creator>Curley, Martha A. Q ; Hibberd, Patricia L ; Fineman, Lori D ; Wypij, David ; Shih, Mei-Chiung ; Thompson, John E ; Grant, Mary Jo C ; Barr, Frederick E ; Cvijanovich, Natalie Z ; Sorce, Lauren ; Luckett, Peter M ; Matthay, Michael A ; Arnold, John H</creator><creatorcontrib>Curley, Martha A. Q ; Hibberd, Patricia L ; Fineman, Lori D ; Wypij, David ; Shih, Mei-Chiung ; Thompson, John E ; Grant, Mary Jo C ; Barr, Frederick E ; Cvijanovich, Natalie Z ; Sorce, Lauren ; Luckett, Peter M ; Matthay, Michael A ; Arnold, John H</creatorcontrib><description>CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe
and to improve oxygenation in pediatric patients with acute lung injury. However,
the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days infants and children
with acute lung injury treated with prone positioning would have more ventilator-free
days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS Multicenter, randomized, controlled clinical trial conducted from August
28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric
intensive care units aged 2 weeks to 18 years who were treated with supine
vs prone positioning. Randomization was concealed and group assignment was
not blinded. INTERVENTION Patients were randomized to either supine or prone positioning within
48 hours of meeting acute lung injury criteria, with those patients in the
prone group being positioned within 4 hours of randomization and remaining
prone for 20 hours each day during the acute phase of their illness for a
maximum of 7 days, after which they were positioned supine. Both groups were
treated using lung protective ventilator and sedation protocols, extubation
readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE Ventilator-free days to day 28. RESULTS The trial was stopped at the planned interim analysis on the basis of
the prespecified futility stopping rule. There were no differences in the
number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5]
supine vs 15.6 [8.6] prone; mean difference, −0.2 days; 95% CI, −3.6
to 3.2; P = .91). After controlling for
age, Pediatric Risk of Mortality III score, direct vs indirect acute lung
injury, and mode of mechanical ventilation at enrollment, the adjusted difference
in ventilator-free days was 0.3 days (95% CI, −3.0 to 3.5; P = .87). There were no differences in the secondary end
points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P>.99), the time to recovery of lung injury (P = .78),
organ-failure−free days (P = .88),
and cognitive impairment (P = .16) or overall
functional health (P = .12) at hospital
discharge or on day 28. CONCLUSION Prone positioning does not significantly reduce ventilator-free days
or improve other clinical outcomes in pediatric patients with acute lung injury.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.294.2.229</identifier><identifier>PMID: 16014597</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Adolescent ; Biological and medical sciences ; Child ; Child, Preschool ; Children & youth ; Clinical outcomes ; Effectiveness studies ; Female ; General aspects ; Humans ; Infant ; Infant, Newborn ; Inpatient care ; Intensive Care Units, Pediatric ; Male ; Medical sciences ; Pediatrics ; Prone Position ; Respiration, Artificial ; Respiratory diseases ; Respiratory Distress Syndrome, Adult - therapy ; Respiratory Distress Syndrome, Newborn - therapy ; Supine Position</subject><ispartof>JAMA : the journal of the American Medical Association, 2005-07, Vol.294 (2), p.229-237</ispartof><rights>2005 INIST-CNRS</rights><rights>Copyright American Medical Association Jul 13, 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.294.2.229$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.294.2.229$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3327,27901,27902,76231,76234</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16929516$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16014597$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Curley, Martha A. Q</creatorcontrib><creatorcontrib>Hibberd, Patricia L</creatorcontrib><creatorcontrib>Fineman, Lori D</creatorcontrib><creatorcontrib>Wypij, David</creatorcontrib><creatorcontrib>Shih, Mei-Chiung</creatorcontrib><creatorcontrib>Thompson, John E</creatorcontrib><creatorcontrib>Grant, Mary Jo C</creatorcontrib><creatorcontrib>Barr, Frederick E</creatorcontrib><creatorcontrib>Cvijanovich, Natalie Z</creatorcontrib><creatorcontrib>Sorce, Lauren</creatorcontrib><creatorcontrib>Luckett, Peter M</creatorcontrib><creatorcontrib>Matthay, Michael A</creatorcontrib><creatorcontrib>Arnold, John H</creatorcontrib><title>Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe
and to improve oxygenation in pediatric patients with acute lung injury. However,
the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days infants and children
with acute lung injury treated with prone positioning would have more ventilator-free
days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS Multicenter, randomized, controlled clinical trial conducted from August
28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric
intensive care units aged 2 weeks to 18 years who were treated with supine
vs prone positioning. Randomization was concealed and group assignment was
not blinded. INTERVENTION Patients were randomized to either supine or prone positioning within
48 hours of meeting acute lung injury criteria, with those patients in the
prone group being positioned within 4 hours of randomization and remaining
prone for 20 hours each day during the acute phase of their illness for a
maximum of 7 days, after which they were positioned supine. Both groups were
treated using lung protective ventilator and sedation protocols, extubation
readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE Ventilator-free days to day 28. RESULTS The trial was stopped at the planned interim analysis on the basis of
the prespecified futility stopping rule. There were no differences in the
number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5]
supine vs 15.6 [8.6] prone; mean difference, −0.2 days; 95% CI, −3.6
to 3.2; P = .91). After controlling for
age, Pediatric Risk of Mortality III score, direct vs indirect acute lung
injury, and mode of mechanical ventilation at enrollment, the adjusted difference
in ventilator-free days was 0.3 days (95% CI, −3.0 to 3.5; P = .87). There were no differences in the secondary end
points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P>.99), the time to recovery of lung injury (P = .78),
organ-failure−free days (P = .88),
and cognitive impairment (P = .16) or overall
functional health (P = .12) at hospital
discharge or on day 28. CONCLUSION Prone positioning does not significantly reduce ventilator-free days
or improve other clinical outcomes in pediatric patients with acute lung injury.</description><subject>Adolescent</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children & youth</subject><subject>Clinical outcomes</subject><subject>Effectiveness studies</subject><subject>Female</subject><subject>General aspects</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Inpatient care</subject><subject>Intensive Care Units, Pediatric</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pediatrics</subject><subject>Prone Position</subject><subject>Respiration, Artificial</subject><subject>Respiratory diseases</subject><subject>Respiratory Distress Syndrome, Adult - therapy</subject><subject>Respiratory Distress Syndrome, Newborn - therapy</subject><subject>Supine Position</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkdFrFDEQxoMo9qy-Cr5IKOjbnplks7vxoXAcVQsHLVLxcZlLsr0c2aQmu0L96430LG1DICHzmy_fzBDyFtgSGINPexxxyVW95EvO1TOyACm6SkjVPScLxlRXtXVXH5FXOe9ZWSDal-QIGga1VO2CpLNhsHqicaCXKQZLL2N2k4vBhWsaA117F5xGTy_mScfRZurK4855k2ygP920oys9T5Zu5pJwHvZzuv1MV_Q7BhNH98cauo5hStH7cr1KDv1r8mJAn-2bw3lMfnw5u1p_qzYXX8_Xq02FQqipGramNpIxKYUFLtBIteXadGULpUVTCmASOWJrwTTciqYRMPBawWAVa2pxTE7vdG_m7WiNtsUG-v4muRHTbR_R9Y8jwe366_i7L7-1TDRF4ONBIMVfs81TP7qsrfcYbJxz33RMQGlxAU-egPs4p1CK6zmUjqsO2gK9f2jn3sf_WRTgwwHAXDo-JAza5Qec4krCP1vv7rgy-vsoZwBdK_4C_iihEw</recordid><startdate>20050713</startdate><enddate>20050713</enddate><creator>Curley, Martha A. Q</creator><creator>Hibberd, Patricia L</creator><creator>Fineman, Lori D</creator><creator>Wypij, David</creator><creator>Shih, Mei-Chiung</creator><creator>Thompson, John E</creator><creator>Grant, Mary Jo C</creator><creator>Barr, Frederick E</creator><creator>Cvijanovich, Natalie Z</creator><creator>Sorce, Lauren</creator><creator>Luckett, Peter M</creator><creator>Matthay, Michael A</creator><creator>Arnold, John H</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20050713</creationdate><title>Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial</title><author>Curley, Martha A. Q ; Hibberd, Patricia L ; Fineman, Lori D ; Wypij, David ; Shih, Mei-Chiung ; Thompson, John E ; Grant, Mary Jo C ; Barr, Frederick E ; Cvijanovich, Natalie Z ; Sorce, Lauren ; Luckett, Peter M ; Matthay, Michael A ; Arnold, John H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a339t-fbd4d500553e123ad59b2cd8cd839c3614505a2aa7e1d62e36631f2491fe90643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adolescent</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children & youth</topic><topic>Clinical outcomes</topic><topic>Effectiveness studies</topic><topic>Female</topic><topic>General aspects</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Inpatient care</topic><topic>Intensive Care Units, Pediatric</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Pediatrics</topic><topic>Prone Position</topic><topic>Respiration, Artificial</topic><topic>Respiratory diseases</topic><topic>Respiratory Distress Syndrome, Adult - therapy</topic><topic>Respiratory Distress Syndrome, Newborn - therapy</topic><topic>Supine Position</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Curley, Martha A. Q</creatorcontrib><creatorcontrib>Hibberd, Patricia L</creatorcontrib><creatorcontrib>Fineman, Lori D</creatorcontrib><creatorcontrib>Wypij, David</creatorcontrib><creatorcontrib>Shih, Mei-Chiung</creatorcontrib><creatorcontrib>Thompson, John E</creatorcontrib><creatorcontrib>Grant, Mary Jo C</creatorcontrib><creatorcontrib>Barr, Frederick E</creatorcontrib><creatorcontrib>Cvijanovich, Natalie Z</creatorcontrib><creatorcontrib>Sorce, Lauren</creatorcontrib><creatorcontrib>Luckett, Peter M</creatorcontrib><creatorcontrib>Matthay, Michael A</creatorcontrib><creatorcontrib>Arnold, John H</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>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Curley, Martha A. Q</au><au>Hibberd, Patricia L</au><au>Fineman, Lori D</au><au>Wypij, David</au><au>Shih, Mei-Chiung</au><au>Thompson, John E</au><au>Grant, Mary Jo C</au><au>Barr, Frederick E</au><au>Cvijanovich, Natalie Z</au><au>Sorce, Lauren</au><au>Luckett, Peter M</au><au>Matthay, Michael A</au><au>Arnold, John H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2005-07-13</date><risdate>2005</risdate><volume>294</volume><issue>2</issue><spage>229</spage><epage>237</epage><pages>229-237</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe
and to improve oxygenation in pediatric patients with acute lung injury. However,
the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days infants and children
with acute lung injury treated with prone positioning would have more ventilator-free
days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS Multicenter, randomized, controlled clinical trial conducted from August
28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric
intensive care units aged 2 weeks to 18 years who were treated with supine
vs prone positioning. Randomization was concealed and group assignment was
not blinded. INTERVENTION Patients were randomized to either supine or prone positioning within
48 hours of meeting acute lung injury criteria, with those patients in the
prone group being positioned within 4 hours of randomization and remaining
prone for 20 hours each day during the acute phase of their illness for a
maximum of 7 days, after which they were positioned supine. Both groups were
treated using lung protective ventilator and sedation protocols, extubation
readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE Ventilator-free days to day 28. RESULTS The trial was stopped at the planned interim analysis on the basis of
the prespecified futility stopping rule. There were no differences in the
number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5]
supine vs 15.6 [8.6] prone; mean difference, −0.2 days; 95% CI, −3.6
to 3.2; P = .91). After controlling for
age, Pediatric Risk of Mortality III score, direct vs indirect acute lung
injury, and mode of mechanical ventilation at enrollment, the adjusted difference
in ventilator-free days was 0.3 days (95% CI, −3.0 to 3.5; P = .87). There were no differences in the secondary end
points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P>.99), the time to recovery of lung injury (P = .78),
organ-failure−free days (P = .88),
and cognitive impairment (P = .16) or overall
functional health (P = .12) at hospital
discharge or on day 28. CONCLUSION Prone positioning does not significantly reduce ventilator-free days
or improve other clinical outcomes in pediatric patients with acute lung injury.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>16014597</pmid><doi>10.1001/jama.294.2.229</doi><tpages>9</tpages></addata></record> |
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source | MEDLINE; American Medical Association Journals |
subjects | Adolescent Biological and medical sciences Child Child, Preschool Children & youth Clinical outcomes Effectiveness studies Female General aspects Humans Infant Infant, Newborn Inpatient care Intensive Care Units, Pediatric Male Medical sciences Pediatrics Prone Position Respiration, Artificial Respiratory diseases Respiratory Distress Syndrome, Adult - therapy Respiratory Distress Syndrome, Newborn - therapy Supine Position |
title | Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial |
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