RANDOMIZED TRIAL OF PROPHYLACTIC EARLY FRESH-FROZEN PLASMA OR GELATINOR GLUCOSE IN PRETERM BABIES - OUTCOME AT 2 YEARS

Background Preterm babies are at risk of haemorrhagic and ischaemic br ain injury. One controlled trial suggested that prophylactic fresh-fro zen plasma (FFP) may reduce that risk but did not clarify whether the reduction in periventricular haemorrhage seen on ultrasonography was d ue to a haemostatic effect or stabilisation of intravascular volume by FFP. We undertook a trial of 776 babies of gestational age at birth l ess than 32 weeks to look at the short-term and long-term outcome afte r early prophylactic FFP. Methods The defined primary trial outcome wa s survival without identifiable major disability 2 years after birth. The babies were randomly allocated, within 2 h of birth, 20 mL/kg FFP followed by a further 10 mL/kg after 24 h; or the same volumes of a ge latin-based plasma substitute; or maintenance infusion of glucose (con trol). The three groups were similar at trial entry. Outcome at discha rge from hospital after birth (reported elsewhere) was similar in the three groups. Findings No child was lost to follow-up, and all the sur viving children underwent neurological and developmental assessment at the age of 2 years. The proportions dying (21.0%, 24.9%, 20.5%), and the proportions of survivors with a severe disability (11.3%, 11.2%, 1 4.1%) did not differ significantly between the randomised groups. The survivors had similar mean developmental quotients at age 2 (Griffiths ' quotients 94, 97, and 95). Interpretation This trial provides no evi dence that the routine early use of FFP, or some other form of intrava scular volume expansion, affects the risk of death or disability in ba bies born more than 8 weeks before term.