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

Eur J Pediatr. 1996 Jul;155(7):580-8. doi: 10.1007/BF01957909.


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%.

Conclusion: Neither early prophylactic volume expansion, nor a coagulation factor supplement, had any detectable effect on short-term outcome in this large multicentre open trial.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Brain Ischemia / complications
  • Brain Ischemia / mortality
  • Brain Ischemia / prevention & control*
  • Cerebral Hemorrhage / complications
  • Cerebral Hemorrhage / mortality
  • Cerebral Hemorrhage / prevention & control*
  • Cerebral Ventricles* / diagnostic imaging
  • Cerebral Ventricles* / physiopathology
  • Echoencephalography
  • England / epidemiology
  • Female
  • Gelatin / therapeutic use*
  • Humans
  • Infant, Newborn
  • Infant, Premature*
  • Infusions, Intravenous
  • Male
  • Plasma Substitutes / therapeutic use*
  • Plasma*


  • Plasma Substitutes
  • Gelatin