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%) ei
ther 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) res
pectively. The findings were similar for all the prespecified subgroup anal
yses stratified by key prognostic factors at trial entry: country of birth,
gestational age < or <greater than or equal to> 29 weeks, inborn or outbor
n, age < or <greater than or equal to> 1 lour, and with or without cerebral
scan abnormality.
Conclusion-These findings do not support the use of etamsylate. Other strat
egies need to be evaluated for the prevention of mortality and morbidity in
these vulnerable infants.