A randomized trial comparing the effect of prophylactic intravenous fresh frozen plasma, gelatin or glucose on early mortality and morbidity in preterm babies. The Northern Neonatal Nursing Initiative [NNNI] Trial Group.
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%.


CONCLUSIONS
Neither early prophylactic volume expansion, nor a coagulation factor supplement, had any detectable effect on short-term outcome in this large multicentre open trial.
D002545:Brain Ischemia / Q000150:complications / Q000401:mortality / Q000517:prevention & control*; D002543:Cerebral Hemorrhage / Q000150:complications / Q000401:mortality / Q000517:prevention & control*; D002552:Cerebral Ventricles / Q000000981:diagnostic imaging / Q000503:physiopathology; D004453:Echoencephalography; D004739:England / Q000453:epidemiology; D005260:Female; D005780:Gelatin / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007262:Infusions, Intravenous; D008297:Male; D010949:Plasma; D010952:Plasma Substitutes / Q000627:therapeutic use*
D010952:Plasma Substitutes; D005780:Gelatin