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Randomised controlled trial of prophylactic etamsylate: follow up at 2 years of age
D Elbourne1, S Ayers, H Dellagrammaticas
1Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK. elbourne@lshtm.ac.uk
Insights
Etamsylate did not reduce brain damage or death in premature infants. Further research is needed to find effective strategies for preventing mortality and morbidity in vulnerable newborns.
Area of Science:
- Neonatal medicine
- Pediatric neurology
- Clinical pharmacology
Background:
- Premature infants are at high risk for brain damage and related complications.
- Etamsylate is a medication sometimes used to prevent bleeding.
Purpose of the Study:
- To evaluate the effectiveness of etamsylate in preventing hemorrhagic brain damage and its consequences in preterm infants.
Main Methods:
- A randomized controlled trial involving 334 infants born before 33 weeks gestation.
- Infants were randomized to receive etamsylate or a placebo within four hours of birth.
- Outcomes assessed at 2 years included death, impairment, and disability.
Main Results:
- No significant difference in death, impairment, or disability rates between the etamsylate and control groups.
- Relative risks for death/impairment and death/severe impairment were 1.14 and 1.17, respectively.
- Subgroup analyses did not reveal any significant benefits of etamsylate.
Conclusions:
- The study findings do not support the use of etamsylate for preventing brain damage in preterm infants.
- Alternative strategies are required to reduce mortality and morbidity in this vulnerable population.
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 >or= 29 weeks, inborn or outborn, age < or >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.