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Arch Dis Child Fetal Neonatal Ed 2001;84:F183-F187 ( May )

Randomised controlled trial of prophylactic etamsylate: follow up at 2 years of age

D Elbournea, S Ayersb, H Dellagrammaticasc, A Johnsonb, M Leloupd, S Lenoir-Piate, on behalf of the EC Ethamsylate Trial Group

a Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, b National Perinatal Epidemiology Unit, Institute of Health Sciences, Old Road, Oxford OX3 7LF, UK, c 2nd Department of Pediatrics, Aglaia Kyriakou Children's Hospital, 11527 Athens, Greece, d Agence Française de Developpement, 5 Rue Roland Barthis, 75012 Paris, France, e Clinique de l'union et du Vaurais, Boulevard de Ratalens, 31240 Saint Jean, France

Correspondence to: Dr Elbourne diana.elbourne{at}lshtm.ac.uk

Accepted 20 December 2000

AIM---To assess the role of etamsylate* in reducing the risk of haemorrhagic brain damage and its consequences.
DESIGN---Follow up of babies recruited into a randomised controlled trial.
METHODS---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.
RESULTS---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 < or >=  29 weeks, inborn or outborn, age < or >=   1 hour, and with or without cerebral scan abnormality.
CONCLUSION---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.


Key messages

  • 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
  • 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
  • Other strategies need to be evaluated for the prevention of mortality and morbidity in these vulnerable infants




Keywords: etamsylate; ethamsylate; preterm; brain; periventricular/intraventricular haemorrhage; childhood disability; randomised controlled trial
* This is the rINN (Recommended International Non-propriety Name) for ethamsylate.

© 2001 by Archives of Disease in Childhood


This article has been cited by other articles:


Home page
 Arch. Dis. Child. Fetal Neonatal Ed.Home page
J Schulte, J Osborne, J W T Benson, R Cooke, M Drayton, J Murphy, J Rennie, and B Speidel
Developmental outcome of the use of etamsylate for prevention of periventricular haemorrhage in a randomised controlled trial
Arch. Dis. Child. Fetal Neonatal Ed., January 1, 2005; 90(1): F31 - F35.
[Abstract] [Full Text] [PDF]


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