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Randomised controlled trial of prophylactic etamsylate: follow up at 2 years of age
  1. D Elbournea,
  2. S Ayersb,
  3. H Dellagrammaticasc,
  4. A Johnsonb,
  5. M Leloupd,
  6. S Lenoir-Piat on behalf of the EC Ethamsylate Trial Groupe
  1. aMedical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, bNational Perinatal Epidemiology Unit, Institute of Health Sciences, Old Road, Oxford OX3 7LF, UK, c2nd Department of Pediatrics, Aglaia Kyriakou Children's Hospital, 11527 Athens, Greece, dAgence Française de Developpement, 5 Rue Roland Barthis, 75012 Paris, France, eClinique de l'union et du Vaurais, Boulevard de Ratalens, 31240 Saint Jean, France
  1. Dr Elbournediana.elbourne{at}lshtm.ac.uk

Abstract

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

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

  • etamsylate
  • ethamsylate
  • preterm
  • brain
  • periventricular/intraventricular haemorrhage
  • childhood disability
  • randomised controlled trial

https://doi.org/10.1136/fn.84.3.F183

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