Vitamin K deficiency bleeding after NICE guidance and withdrawal of Konakion Neonatal: British Paediatric Surveillance Unit study, 2006–2008
Objective To survey vitamin K deficiency bleeding (VKDB) and document vitamin K (VK) prophylaxis practice, and compare with findings predating withdrawal of Konakion Neonatal and guidance from the National Institute of Health and Clinical Excellence (NICE), both occurring in 2006. Design Two-year su...
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| Veröffentlicht in: | Archives of disease in childhood 2013-01, Vol.98 (1), p.41-47 |
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| creator | Busfield, Alison Samuel, Rebecca McNinch, Andrew Tripp, John H |
| description | Objective To survey vitamin K deficiency bleeding (VKDB) and document vitamin K (VK) prophylaxis practice, and compare with findings predating withdrawal of Konakion Neonatal and guidance from the National Institute of Health and Clinical Excellence (NICE), both occurring in 2006. Design Two-year surveillance of VKDB (2006–2008) using British Paediatric Surveillance Unit methodology. Postal questionnaire to consultant-led maternity units. Setting UK and Irish Republic. Patients All newborns and infants under 6 months with suspected VKDB. Main outcome measures VKDB incidence and predisposing factors, VK prophylaxis recommended/received. Results Eleven cases of VKDB were found: six (55%) babies received no VK prophylaxis, in five (45.5%) because parents withheld consent; three (27.5%) babies with late VKDB received intramuscular (IM) Konakion MM (two had biliary atresia, and one was delivered preterm); two (18%) babies received incomplete oral prophylaxis. Nine babies (82%) were breast fed. Three (27%) babies had liver disease; four (36%), including all those with liver disease, were jaundiced at presentation after 21 days. Four (36%) babies had intracranial haemorrhage, two probably suffering long-term morbidity. VK prophylaxis practice was defined in 236 (100%) units. All units recommended prophylaxis for every newborn: 169 (72%) IM, 19 (8%) oral, and 48 (20%) offered parental choice. All units that recommended IM prophylaxis used Konakion MM. Oral prophylaxis always involved multidose regimens for breastfed babies; 61 (91%) units used Konakion MM, and six (9%) used unlicensed products suitable for administration by parents. Conclusions IM Konakion MM is efficacious, but parents withholding consent for recommended IM prophylaxis reduces effectiveness. Reappraisal of NICE guidance would be appropriate. Prolonged jaundice demands investigation. Late VKDB occasionally occurs after IM prophylaxis. |
| doi_str_mv | 10.1136/archdischild-2011-301029 |
| format | Article |
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Design Two-year surveillance of VKDB (2006–2008) using British Paediatric Surveillance Unit methodology. Postal questionnaire to consultant-led maternity units. Setting UK and Irish Republic. Patients All newborns and infants under 6 months with suspected VKDB. Main outcome measures VKDB incidence and predisposing factors, VK prophylaxis recommended/received. Results Eleven cases of VKDB were found: six (55%) babies received no VK prophylaxis, in five (45.5%) because parents withheld consent; three (27.5%) babies with late VKDB received intramuscular (IM) Konakion MM (two had biliary atresia, and one was delivered preterm); two (18%) babies received incomplete oral prophylaxis. Nine babies (82%) were breast fed. Three (27%) babies had liver disease; four (36%), including all those with liver disease, were jaundiced at presentation after 21 days. Four (36%) babies had intracranial haemorrhage, two probably suffering long-term morbidity. VK prophylaxis practice was defined in 236 (100%) units. All units recommended prophylaxis for every newborn: 169 (72%) IM, 19 (8%) oral, and 48 (20%) offered parental choice. All units that recommended IM prophylaxis used Konakion MM. Oral prophylaxis always involved multidose regimens for breastfed babies; 61 (91%) units used Konakion MM, and six (9%) used unlicensed products suitable for administration by parents. Conclusions IM Konakion MM is efficacious, but parents withholding consent for recommended IM prophylaxis reduces effectiveness. Reappraisal of NICE guidance would be appropriate. Prolonged jaundice demands investigation. Late VKDB occasionally occurs after IM prophylaxis.</description><identifier>ISSN: 0003-9888</identifier><identifier>EISSN: 1468-2044</identifier><identifier>DOI: 10.1136/archdischild-2011-301029</identifier><identifier>PMID: 23148314</identifier><identifier>CODEN: ADCHAK</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</publisher><subject>Biological and medical sciences ; bleeding ; Company distribution practices ; Demographic aspects ; Disease prevention ; Distribution ; Female ; General aspects ; Guidance ; Humans ; Incidence ; Infant ; Infant, Newborn ; Ireland - epidemiology ; Liver diseases ; Male ; Medical sciences ; Metabolic diseases ; Miscellaneous ; Newborn ; Other nutritional diseases (malnutrition, nutritional and vitamin deficiencies...) ; Pediatrics ; Practice Guidelines as Topic ; Prevention and actions ; Prophylaxis ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Questionnaires ; Sentinel health events ; Sentinel surveillance ; Surveillance ; Surveys and Questionnaires ; United Kingdom - epidemiology ; Vitamin k ; Vitamin K 1 - administration & dosage ; Vitamin K deficiency ; Vitamin K Deficiency Bleeding - drug therapy ; Vitamin K Deficiency Bleeding - epidemiology ; Withholding Treatment</subject><ispartof>Archives of disease in childhood, 2013-01, Vol.98 (1), p.41-47</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>2014 INIST-CNRS</rights><rights>Copyright: 2012 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b526t-f1f8810bcf756cc58d5c84de1dc1d5390c8645705fc337f018d7b9016286ed933</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://adc.bmj.com/content/98/1/41.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://adc.bmj.com/content/98/1/41.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,314,780,784,3196,4024,23571,27923,27924,27925,77600,77631</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26764968$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23148314$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Busfield, Alison</creatorcontrib><creatorcontrib>Samuel, Rebecca</creatorcontrib><creatorcontrib>McNinch, Andrew</creatorcontrib><creatorcontrib>Tripp, John H</creatorcontrib><title>Vitamin K deficiency bleeding after NICE guidance and withdrawal of Konakion Neonatal: British Paediatric Surveillance Unit study, 2006–2008</title><title>Archives of disease in childhood</title><addtitle>Arch Dis Child</addtitle><description>Objective To survey vitamin K deficiency bleeding (VKDB) and document vitamin K (VK) prophylaxis practice, and compare with findings predating withdrawal of Konakion Neonatal and guidance from the National Institute of Health and Clinical Excellence (NICE), both occurring in 2006. Design Two-year surveillance of VKDB (2006–2008) using British Paediatric Surveillance Unit methodology. Postal questionnaire to consultant-led maternity units. Setting UK and Irish Republic. Patients All newborns and infants under 6 months with suspected VKDB. Main outcome measures VKDB incidence and predisposing factors, VK prophylaxis recommended/received. Results Eleven cases of VKDB were found: six (55%) babies received no VK prophylaxis, in five (45.5%) because parents withheld consent; three (27.5%) babies with late VKDB received intramuscular (IM) Konakion MM (two had biliary atresia, and one was delivered preterm); two (18%) babies received incomplete oral prophylaxis. Nine babies (82%) were breast fed. Three (27%) babies had liver disease; four (36%), including all those with liver disease, were jaundiced at presentation after 21 days. Four (36%) babies had intracranial haemorrhage, two probably suffering long-term morbidity. VK prophylaxis practice was defined in 236 (100%) units. All units recommended prophylaxis for every newborn: 169 (72%) IM, 19 (8%) oral, and 48 (20%) offered parental choice. All units that recommended IM prophylaxis used Konakion MM. Oral prophylaxis always involved multidose regimens for breastfed babies; 61 (91%) units used Konakion MM, and six (9%) used unlicensed products suitable for administration by parents. Conclusions IM Konakion MM is efficacious, but parents withholding consent for recommended IM prophylaxis reduces effectiveness. Reappraisal of NICE guidance would be appropriate. Prolonged jaundice demands investigation. Late VKDB occasionally occurs after IM prophylaxis.</description><subject>Biological and medical sciences</subject><subject>bleeding</subject><subject>Company distribution practices</subject><subject>Demographic aspects</subject><subject>Disease prevention</subject><subject>Distribution</subject><subject>Female</subject><subject>General aspects</subject><subject>Guidance</subject><subject>Humans</subject><subject>Incidence</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Ireland - epidemiology</subject><subject>Liver diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Metabolic diseases</subject><subject>Miscellaneous</subject><subject>Newborn</subject><subject>Other nutritional diseases (malnutrition, nutritional and vitamin deficiencies...)</subject><subject>Pediatrics</subject><subject>Practice Guidelines as Topic</subject><subject>Prevention and actions</subject><subject>Prophylaxis</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Questionnaires</subject><subject>Sentinel health events</subject><subject>Sentinel surveillance</subject><subject>Surveillance</subject><subject>Surveys and Questionnaires</subject><subject>United Kingdom - epidemiology</subject><subject>Vitamin k</subject><subject>Vitamin K 1 - administration & dosage</subject><subject>Vitamin K deficiency</subject><subject>Vitamin K Deficiency Bleeding - drug therapy</subject><subject>Vitamin K Deficiency Bleeding - epidemiology</subject><subject>Withholding Treatment</subject><issn>0003-9888</issn><issn>1468-2044</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNks9uEzEQxlcIREPhFZAlhMSBBY-96_VyK1GBqlWKoO3V8vpP4tTZLbaXkhtPwIU35ElwSGgRFzhYY41_M_rG8xUFAvwCgLKXMqiFdlEtnNclwQAlxYBJe6eYQMV4TlXV3WKCMaZlyznfKx7EuMQYCOf0frFHKFQ8n0nx7cIluXI9OkbaWKec6dUadd4Y7fo5kjaZgGZH00M0H52WvTJI9hpdu7TQQV5LjwaLjodeXrqhRzOTb0n6V-h1cMnFBXovcyOZglPo4xg-G-f9rybnvUsoplGvnyOCMfvx9XsO_GFxz0ofzaNd3C_O3xyeTd-VJ6dvj6YHJ2VXE5ZKC5ZzwJ2yTc2UqrmuFa-0Aa1A17TFirOqbnBtFaWNxcB107UYGOHM6JbS_eLZtu9VGD6NJiaxyt9pNuLMMEYBFGoGDEj7b5Q0lAAHgjP65C90OYyhz4MI4IS3mcRVpsotNZfeCNeroU_mS1KD92ZuRJ5zeioOKDSUk7rd8HzLqzDEGIwVV8GtZFgLwGJjB_GnHcTGDmJrh1z6eCdo7FZG3xT-3n8Gnu4AGZX0NuTluHjLsYZVLeO3ml3MWm_eZbgUrKFNLWYXU8FmHwDjWSvOMk-3fLda_r_cn8MC3sw</recordid><startdate>201301</startdate><enddate>201301</enddate><creator>Busfield, Alison</creator><creator>Samuel, Rebecca</creator><creator>McNinch, Andrew</creator><creator>Tripp, John H</creator><general>BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</general><general>BMJ Publishing Group</general><general>BMJ Publishing Group Ltd</general><general>BMJ Publishing Group LTD</general><scope>BSCLL</scope><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>0-V</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88B</scope><scope>88E</scope><scope>88I</scope><scope>8A4</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>CJNVE</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>LK8</scope><scope>M0P</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEDU</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>ASE</scope><scope>FPQ</scope><scope>K6X</scope></search><sort><creationdate>201301</creationdate><title>Vitamin K deficiency bleeding after NICE guidance and withdrawal of Konakion Neonatal: British Paediatric Surveillance Unit study, 2006–2008</title><author>Busfield, Alison ; Samuel, Rebecca ; McNinch, Andrew ; Tripp, John H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b526t-f1f8810bcf756cc58d5c84de1dc1d5390c8645705fc337f018d7b9016286ed933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Biological and medical sciences</topic><topic>bleeding</topic><topic>Company distribution practices</topic><topic>Demographic aspects</topic><topic>Disease prevention</topic><topic>Distribution</topic><topic>Female</topic><topic>General aspects</topic><topic>Guidance</topic><topic>Humans</topic><topic>Incidence</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Ireland - epidemiology</topic><topic>Liver diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Metabolic diseases</topic><topic>Miscellaneous</topic><topic>Newborn</topic><topic>Other nutritional diseases (malnutrition, nutritional and vitamin deficiencies...)</topic><topic>Pediatrics</topic><topic>Practice Guidelines as Topic</topic><topic>Prevention and actions</topic><topic>Prophylaxis</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Questionnaires</topic><topic>Sentinel health events</topic><topic>Sentinel surveillance</topic><topic>Surveillance</topic><topic>Surveys and Questionnaires</topic><topic>United Kingdom - epidemiology</topic><topic>Vitamin k</topic><topic>Vitamin K 1 - administration & dosage</topic><topic>Vitamin K deficiency</topic><topic>Vitamin K Deficiency Bleeding - drug therapy</topic><topic>Vitamin K Deficiency Bleeding - epidemiology</topic><topic>Withholding Treatment</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Busfield, Alison</creatorcontrib><creatorcontrib>Samuel, Rebecca</creatorcontrib><creatorcontrib>McNinch, Andrew</creatorcontrib><creatorcontrib>Tripp, John H</creatorcontrib><collection>Istex</collection><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>ProQuest Social Sciences Premium Collection</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Education Database (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>Education Periodicals</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Social Science Premium Collection</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Education Collection</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Education Database</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>ProQuest One Education</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>British Nursing Index</collection><jtitle>Archives of disease in childhood</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Busfield, Alison</au><au>Samuel, Rebecca</au><au>McNinch, Andrew</au><au>Tripp, John H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Vitamin K deficiency bleeding after NICE guidance and withdrawal of Konakion Neonatal: British Paediatric Surveillance Unit study, 2006–2008</atitle><jtitle>Archives of disease in childhood</jtitle><addtitle>Arch Dis Child</addtitle><date>2013-01</date><risdate>2013</risdate><volume>98</volume><issue>1</issue><spage>41</spage><epage>47</epage><pages>41-47</pages><issn>0003-9888</issn><eissn>1468-2044</eissn><coden>ADCHAK</coden><abstract>Objective To survey vitamin K deficiency bleeding (VKDB) and document vitamin K (VK) prophylaxis practice, and compare with findings predating withdrawal of Konakion Neonatal and guidance from the National Institute of Health and Clinical Excellence (NICE), both occurring in 2006. Design Two-year surveillance of VKDB (2006–2008) using British Paediatric Surveillance Unit methodology. Postal questionnaire to consultant-led maternity units. Setting UK and Irish Republic. Patients All newborns and infants under 6 months with suspected VKDB. Main outcome measures VKDB incidence and predisposing factors, VK prophylaxis recommended/received. Results Eleven cases of VKDB were found: six (55%) babies received no VK prophylaxis, in five (45.5%) because parents withheld consent; three (27.5%) babies with late VKDB received intramuscular (IM) Konakion MM (two had biliary atresia, and one was delivered preterm); two (18%) babies received incomplete oral prophylaxis. Nine babies (82%) were breast fed. Three (27%) babies had liver disease; four (36%), including all those with liver disease, were jaundiced at presentation after 21 days. Four (36%) babies had intracranial haemorrhage, two probably suffering long-term morbidity. VK prophylaxis practice was defined in 236 (100%) units. All units recommended prophylaxis for every newborn: 169 (72%) IM, 19 (8%) oral, and 48 (20%) offered parental choice. All units that recommended IM prophylaxis used Konakion MM. Oral prophylaxis always involved multidose regimens for breastfed babies; 61 (91%) units used Konakion MM, and six (9%) used unlicensed products suitable for administration by parents. Conclusions IM Konakion MM is efficacious, but parents withholding consent for recommended IM prophylaxis reduces effectiveness. Reappraisal of NICE guidance would be appropriate. Prolonged jaundice demands investigation. Late VKDB occasionally occurs after IM prophylaxis.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</pub><pmid>23148314</pmid><doi>10.1136/archdischild-2011-301029</doi><tpages>7</tpages></addata></record> |
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| subjects | Biological and medical sciences bleeding Company distribution practices Demographic aspects Disease prevention Distribution Female General aspects Guidance Humans Incidence Infant Infant, Newborn Ireland - epidemiology Liver diseases Male Medical sciences Metabolic diseases Miscellaneous Newborn Other nutritional diseases (malnutrition, nutritional and vitamin deficiencies...) Pediatrics Practice Guidelines as Topic Prevention and actions Prophylaxis Public health. Hygiene Public health. Hygiene-occupational medicine Questionnaires Sentinel health events Sentinel surveillance Surveillance Surveys and Questionnaires United Kingdom - epidemiology Vitamin k Vitamin K 1 - administration & dosage Vitamin K deficiency Vitamin K Deficiency Bleeding - drug therapy Vitamin K Deficiency Bleeding - epidemiology Withholding Treatment |
| title | Vitamin K deficiency bleeding after NICE guidance and withdrawal of Konakion Neonatal: British Paediatric Surveillance Unit study, 2006–2008 |
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