A RANDOMIZED TRIAL COMPARING THE EFFECT OF PROPHYLACTIC INTRAVENOUS FRESH-FROZEN PLASMA, GELATIN OR GLUCOSE ON EARLY MORTALITY AND MORBIDITY IN PRETERM BABIES

Seven hundred and seventy-six children born before 32 weeks gestation between 1990 and 1992 were randomly allocated within 2 h of birth to o ne of three groups: either prophylactic fresh frozen plasma (20 ml/kg followed by 10 ml/kg after 24 h); or a similar volume of an inert gela tin plasma substitute (Gelofusine); or control management with a maint enance infusion of 10% dextrose. The three groups were similar at tria l entry. There were no statistically significant differences in the nu mber of deaths before discharge (fresh frozen plasma 19.1%, gelatin 22 .0% and control 17.8%). Death or disability amongst long-term survivor s at 2 years of age is the primary trial outcome variable: this inform ation is not yet available. Death before discharge from hospital or th e presence of a cerebral ultrasound scan abnormality 1 or 6 weeks afte r birth in survivors was a pre-defined secondary outcome variable (alt hough 176 long-term survivors never had a scan, largely because they n ever needed care in a unit staffed to provide prolonged respiratory su pport or a routine scan service). Of the children entered into the thr ee arms of the trial, 43.0%, 37.5% and 42.3% respectively died or were known to have developed at least a minor cerebral ultrasound abnormal ity before discharge. The proportions dead or known to have developed a major scan abnormality (ventriculomegaly or a persisting parenchymal abnormality), were 22.7%, 27.0% and 23.3%. Conclusion Neither early p rophylactic volume expansion, nor a coagulation factor supplement, had any detectable effect on short-term outcome in this large multicentre open trial.