rFVII for Pediatric Acute Intracranial Hemorrhage

To the Editor:A recent interesting phase IIB randomized, double-blind, placebo-controlled, dose-ranging “proof-of-concept” trial on recombinant activated factor VII (rFVIIa) for acute intracranial hemorrhage in adult patients has been reported.1 A lacking of similar experience in the pediatric population is noted. rFVIIa has been anecdotally reported as effective for profound bleeding episodes in children. In the pediatric literature, case reports have been made with apparent clinical improvement seen after the use of rFVIIa for acute life-threatening bleeding; however, there are limited data regarding its use in infants younger than 4 months of age, regardless of whether it is a congenital or acquired condition.2–3We report on a case of acute intracranial hemorrhage in a newborn with congenital factor VII deficiency treated with rFVIIa and given a prophylactic program during a follow-up of 36 months. A full-term newborn boy, the first child of nonrelated black parents, was born to his mother aged 29, and the father was 28 years old. The family history was unremarkable. The pregnancy was uneventful. Her birth weight was 2800 g, height was 47.0 cm, and cranial perimeter …