Recombinant activated Factor VII for prevention and treatment of intraventricular haemorrhage in neonates

To assess the efficacy and safety of recombinant activated factor VII in the prevention or treatment of intraventricular haemorrhage in premature infants.

The secondary objective is to perform subgroup analyses based on:

  1. dose (low versus high), frequency (4 versus 6 hourly) and duration (3 versus 5 days) of rVIIa;
  2. gestational age in the prevention (less than 26 weeks versus 26 weeks or more) and treatment (less than 26 weeks versus 26 weeks or more) studies;
  3. status of IVH (known or unknown) at enrolment in prevention studies.

This is a protocol.

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