Phenobarbitone in Rh Hemolytic Disease of the Newborn: A Randomized Double-Blinded Placebo-Controlled Trial
To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn. In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' ges...
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| Veröffentlicht in: | Journal of tropical pediatrics (1980) 2013-10, Vol.59 (5), p.380-386 |
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| container_title | Journal of tropical pediatrics (1980) |
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| creator | VENKATNARAYAN, Kannan MARI JEEVA SANKAR AGARWAL, Ramesh PAUL, Vinod K DEORARI, Ashok K |
| description | To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn.
In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy.
Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04).
PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies. |
| doi_str_mv | 10.1093/tropej/fmt032 |
| format | Article |
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In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy.
Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04).
PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies.</description><identifier>ISSN: 0142-6338</identifier><identifier>EISSN: 1465-3664</identifier><identifier>DOI: 10.1093/tropej/fmt032</identifier><identifier>PMID: 23748474</identifier><identifier>CODEN: JTRPAO</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Bilirubin - blood ; Biological and medical sciences ; Double-Blind Method ; Drug Administration Schedule ; Erythroblastosis, Fetal - drug therapy ; Female ; General aspects ; Gestational Age ; Humans ; Infant, Newborn ; Male ; Medical sciences ; Phenobarbital - administration & dosage ; Phototherapy - methods ; Treatment Outcome</subject><ispartof>Journal of tropical pediatrics (1980), 2013-10, Vol.59 (5), p.380-386</ispartof><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c362t-fda7f7e11e98662c0137ae12af3206851f0fb1046ceb06d40426a00f8dbc7c693</citedby><cites>FETCH-LOGICAL-c362t-fda7f7e11e98662c0137ae12af3206851f0fb1046ceb06d40426a00f8dbc7c693</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27798878$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23748474$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>VENKATNARAYAN, Kannan</creatorcontrib><creatorcontrib>MARI JEEVA SANKAR</creatorcontrib><creatorcontrib>AGARWAL, Ramesh</creatorcontrib><creatorcontrib>PAUL, Vinod K</creatorcontrib><creatorcontrib>DEORARI, Ashok K</creatorcontrib><title>Phenobarbitone in Rh Hemolytic Disease of the Newborn: A Randomized Double-Blinded Placebo-Controlled Trial</title><title>Journal of tropical pediatrics (1980)</title><addtitle>J Trop Pediatr</addtitle><description>To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn.
In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy.
Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04).
PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies.</description><subject>Bilirubin - blood</subject><subject>Biological and medical sciences</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Erythroblastosis, Fetal - drug therapy</subject><subject>Female</subject><subject>General aspects</subject><subject>Gestational Age</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Phenobarbital - administration & dosage</subject><subject>Phototherapy - methods</subject><subject>Treatment Outcome</subject><issn>0142-6338</issn><issn>1465-3664</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkE1PGzEQhq2qqATokSvypVIv2_grtpdbGmiDhAAhOK-83rHi4LWDvRGCX89WCeU0ekeP3hk9CJ1S8ouSmk-HnDawnrp-IJx9QRMq5KziUoqvaEKoYJXkXB-io1LWhBCmhfiGDhlXQgslJujpbgUxtSa3fkgRsI_4foWX0KfwOniLL3wBUwAnh4cV4Bt4aVOO53iO703sUu_foMMXadsGqH4HH7sx3gVjoU3VIsXxuxDG1UP2JpygA2dCge_7eYwe_1w-LJbV9e3fq8X8urJcsqFynVFOAaVQaymZJZQrA5QZxxmRekYdcS0lQo5HiOwEEUwaQpzuWqusrPkx-rnr3eT0vIUyNL0vFkIwEdK2NFQIzmtFZ3pEqx1qcyolg2s22fcmvzaUNP_8Nju_zc7vyJ_tq7dtD91_-kPoCPzYA6ZYE1w20fryySlVa600fwcbLoWY</recordid><startdate>20131001</startdate><enddate>20131001</enddate><creator>VENKATNARAYAN, Kannan</creator><creator>MARI JEEVA SANKAR</creator><creator>AGARWAL, Ramesh</creator><creator>PAUL, Vinod K</creator><creator>DEORARI, Ashok K</creator><general>Oxford University Press</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>7X8</scope></search><sort><creationdate>20131001</creationdate><title>Phenobarbitone in Rh Hemolytic Disease of the Newborn: A Randomized Double-Blinded Placebo-Controlled Trial</title><author>VENKATNARAYAN, Kannan ; MARI JEEVA SANKAR ; AGARWAL, Ramesh ; PAUL, Vinod K ; DEORARI, Ashok K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c362t-fda7f7e11e98662c0137ae12af3206851f0fb1046ceb06d40426a00f8dbc7c693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Bilirubin - blood</topic><topic>Biological and medical sciences</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Erythroblastosis, Fetal - drug therapy</topic><topic>Female</topic><topic>General aspects</topic><topic>Gestational Age</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Phenobarbital - administration & dosage</topic><topic>Phototherapy - methods</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>VENKATNARAYAN, Kannan</creatorcontrib><creatorcontrib>MARI JEEVA SANKAR</creatorcontrib><creatorcontrib>AGARWAL, Ramesh</creatorcontrib><creatorcontrib>PAUL, Vinod K</creatorcontrib><creatorcontrib>DEORARI, Ashok K</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>MEDLINE - Academic</collection><jtitle>Journal of tropical pediatrics (1980)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>VENKATNARAYAN, Kannan</au><au>MARI JEEVA SANKAR</au><au>AGARWAL, Ramesh</au><au>PAUL, Vinod K</au><au>DEORARI, Ashok K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phenobarbitone in Rh Hemolytic Disease of the Newborn: A Randomized Double-Blinded Placebo-Controlled Trial</atitle><jtitle>Journal of tropical pediatrics (1980)</jtitle><addtitle>J Trop Pediatr</addtitle><date>2013-10-01</date><risdate>2013</risdate><volume>59</volume><issue>5</issue><spage>380</spage><epage>386</epage><pages>380-386</pages><issn>0142-6338</issn><eissn>1465-3664</eissn><coden>JTRPAO</coden><abstract>To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn.
In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy.
Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04).
PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>23748474</pmid><doi>10.1093/tropej/fmt032</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of tropical pediatrics (1980), 2013-10, Vol.59 (5), p.380-386 |
| issn | 0142-6338 1465-3664 |
| language | eng |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Bilirubin - blood Biological and medical sciences Double-Blind Method Drug Administration Schedule Erythroblastosis, Fetal - drug therapy Female General aspects Gestational Age Humans Infant, Newborn Male Medical sciences Phenobarbital - administration & dosage Phototherapy - methods Treatment Outcome |
| title | Phenobarbitone in Rh Hemolytic Disease of the Newborn: A Randomized Double-Blinded Placebo-Controlled Trial |
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