A randomized trial comparing the effect of prophylactic intravenous fresh frozen plasma, gelatin or glucose on early mortality and morbidity in preterm babies

Abstract

Seven hundred and seventy-six children born before 32 weeks gestation between 1990 and 1992 were randomly allocated within 2 h of birth to one 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 gelatin plasma substitute (Gelofusine); or control management with a maintenance infusion of 10% dextrose. The three groups were similar at trial entry. There were no statistically significant differences in the number of deaths before discharge (fresh frozen plasma 19.1%, gelatin 22.0% and control 17.8%). Death or disability amongst long-term survivors at 2 years of age, is the primary trial outcome variable: this information is not yet available. Death before discharge from hospital or the presence of a cerebral ultrasound scan abnormality 1 or 6 weeks after birth in survivors was a pre-defined secondary outcome variable (although 176 long-term survivors never had a scan, largely because they never needed care in a unit staffed to provide prolonged respiratory support or a routine scan service). Of the children entered into the three 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 abnormality 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%.