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

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

Measuring functional outcomes after prematurity: Developmental impact of very low birth weight and extremely low birth weight status on childhood disability

“…Schmidt questioned if endpoints chosen for many neonatal randomized control trials were sensitive to detecting impact on disability outcomes. Elbourne et al [2001] evaluated the impact of ethamsylate on the prevention of IVH and subsequent death or disability on VLBW neonates Ͻ33 weeks. Neuromotor disability at age 2 years was classified as moderate if the child was unable to sit, needed help to walk, or had difficulty using his hands.…”

Molecular Mechanisms Regulating the Vascular Prostacyclin Pathways and Their Adaptation during Pregnancy and in the Newborn

“…The second trial, in which 334 premature infants received ethamsylate in the first 4 h after birth, showed no difference in incidence of IVH compared with placebo group. In both trials, long-term patient follow-up showed no benefits in neurodevelopmental outcomes and neuromotor or cognitive function (Elbourne et al, 2001;Schulte et al, 2005). Failure of indomethacin and ethamsylate to improve the IVH global outcome is probably attributable to the fact that although COX inhibition may prevent the initial increase in CBF causing IVH, it could lead to harmful neuronal effects.…”

Developmental outcome of the use of etamsylate for prevention of periventricular haemorrhage in a randomised controlled trial

“…This is not supported by the follow up of the EC trial, in which deaths were similar in the etamsylate and placebo groups. 16 The EC trial also failed to detect any long term benefit of etamsylate treatment, but did not report on the incidence of patent ductus. They did not find a reduction in the number of squints.…”