{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T02:45:15Z","timestamp":1790736315307,"version":"4.1.0"},"reference-count":11,"publisher":"BMJ","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arch Dis Child Fetal Neonatal Ed"],"accepted":{"date-parts":[[2000,12,20]]},"published-print":{"date-parts":[[2001,5,1]]},"abstract":"\n AIM<\/jats:title>\n To assess the role of etamsylate* in reducing the risk of haemorrhagic brain damage and its consequences.<\/jats:p>\n <\/jats:sec>\n \n DESIGN<\/jats:title>\n Follow up of babies recruited into a randomised controlled trial.<\/jats:p>\n <\/jats:sec>\n \n METHODS<\/jats:title>\n A total of 334 infants born before 33 weeks gestation in France and Greece were randomly allocated within the first four hours of birth either to receive etamsylate or to act as controls. The principal outcomes in the trial were death or impairment and\/or disability at the age of 2 years.<\/jats:p>\n <\/jats:sec>\n \n RESULTS<\/jats:title>\n Fifty nine children were lost to follow up. A total of 115 (34%) either died or had some impairment or disability, and 88 (26%) either died or had severe impairment or disability at 2 years of age. These outcomes did not differ significantly between the two randomised groups: relative risks and 95% confidence intervals 1.14 (0.78 to 1.4) and 1.17 (0.82 to 1.68) respectively. The findings were similar for all the prespecified subgroup analyses stratified by key prognostic factors at trial entry: country of birth, gestational age\u2009<\u2009or\u2009\u2a7e\u200929 weeks, inborn or outborn, age\u2009<\u2009or\u2009\u2a7e\u2009 1 hour, and with or without cerebral scan abnormality.<\/jats:p>\n <\/jats:sec>\n \n CONCLUSION<\/jats:title>\n These findings do not support the use of etamsylate. Other strategies need to be evaluated for the prevention of mortality and morbidity in these vulnerable infants.<\/jats:p>\n \n \n \n Key messages<\/jats:title>\n \n \n The findings from the only published follow up of children from a randomised controlled trial of etamsylate do not support its use when given within the first four hours of birth to infants born before 33 weeks gestation<\/jats:p>\n <\/jats:list-item>\n \n Centres in Greece and France recruited 334 infants into the trial, and did not find that etamsylate reduced the risk of haemorrhagic brain damage or its consequences in terms of death or impairment and\/or disability<\/jats:p>\n <\/jats:list-item>\n \n Other strategies need to be evaluated for the prevention of mortality and morbidity in these vulnerable infants<\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:sec>\n <\/jats:boxed-text>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/fn.84.3.f183","type":"journal-article","created":{"date-parts":[[2002,7,27]],"date-time":"2002-07-27T06:40:22Z","timestamp":1027752022000},"page":"F183-F187","source":"Crossref","is-referenced-by-count":23,"title":["Randomised controlled trial of prophylactic etamsylate: follow up at 2 years of age"],"prefix":"10.1136","volume":"84","author":[{"given":"D","family":"Elbourne","sequence":"first","affiliation":[{"name":"aMedical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, \n\nbNational Perinatal Epidemiology Unit, Institute of Health Sciences, Old Road, Oxford OX3 7LF, UK, \n\nc2nd Department of Pediatrics, Aglaia Kyriakou Children's Hospital, 11527 Athens, Greece, \n\ndAgence Fran\u00e7aise de Developpement, 5 Rue Roland Barthis, 75012 Paris, France, \n\neClinique de l'union et du Vaurais, Boulevard de Ratalens, 31240 Saint Jean, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Ayers","sequence":"additional","affiliation":[{"name":"aMedical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, \n\nbNational Perinatal Epidemiology Unit, Institute of Health Sciences, Old Road, Oxford OX3 7LF, UK, \n\nc2nd Department of Pediatrics, Aglaia Kyriakou Children's Hospital, 11527 Athens, Greece, \n\ndAgence Fran\u00e7aise de Developpement, 5 Rue Roland Barthis, 75012 Paris, France, \n\neClinique de l'union et du Vaurais, Boulevard de Ratalens, 31240 Saint Jean, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H","family":"Dellagrammaticas","sequence":"additional","affiliation":[{"name":"aMedical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, \n\nbNational Perinatal Epidemiology Unit, Institute of Health Sciences, Old Road, Oxford OX3 7LF, UK, \n\nc2nd Department of Pediatrics, Aglaia Kyriakou Children's Hospital, 11527 Athens, Greece, \n\ndAgence Fran\u00e7aise de Developpement, 5 Rue Roland Barthis, 75012 Paris, France, \n\neClinique de l'union et du Vaurais, Boulevard de Ratalens, 31240 Saint Jean, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Johnson","sequence":"additional","affiliation":[{"name":"aMedical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, \n\nbNational Perinatal Epidemiology Unit, Institute of Health Sciences, Old Road, Oxford OX3 7LF, UK, \n\nc2nd Department of Pediatrics, Aglaia Kyriakou Children's Hospital, 11527 Athens, Greece, \n\ndAgence Fran\u00e7aise de Developpement, 5 Rue Roland Barthis, 75012 Paris, France, \n\neClinique de l'union et du Vaurais, Boulevard de Ratalens, 31240 Saint Jean, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Leloup","sequence":"additional","affiliation":[{"name":"aMedical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, \n\nbNational Perinatal Epidemiology Unit, Institute of Health Sciences, Old Road, Oxford OX3 7LF, UK, \n\nc2nd Department of Pediatrics, Aglaia Kyriakou Children's Hospital, 11527 Athens, Greece, \n\ndAgence Fran\u00e7aise de Developpement, 5 Rue Roland Barthis, 75012 Paris, France, \n\neClinique de l'union et du Vaurais, Boulevard de Ratalens, 31240 Saint Jean, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Lenoir-Piat","sequence":"additional","affiliation":[{"name":"aMedical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, \n\nbNational Perinatal Epidemiology Unit, Institute of Health Sciences, Old Road, Oxford OX3 7LF, UK, \n\nc2nd Department of Pediatrics, Aglaia Kyriakou Children's Hospital, 11527 Athens, Greece, \n\ndAgence Fran\u00e7aise de Developpement, 5 Rue Roland Barthis, 75012 Paris, France, \n\neClinique de l'union et du Vaurais, Boulevard de Ratalens, 31240 Saint Jean, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2001,5,1]]},"reference":[{"key":"2025090514280805000_84.3.F183.1","doi-asserted-by":"publisher","DOI":"10.1136\/fn.74.2.F118"},{"key":"2025090514280805000_84.3.F183.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(81)91103-X"},{"key":"2025090514280805000_84.3.F183.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(86)91432-7"},{"key":"2025090514280805000_84.3.F183.4","doi-asserted-by":"publisher","DOI":"10.1136\/fn.70.3.F201"},{"key":"2025090514280805000_84.3.F183.5","first-page":"889","article-title":"Ethamsylate in the prevention of prevention periventricular-intraventricular haemorrhage in premature 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