European Journal of Pediatrics

, Volume 155, Issue 7, pp 580–588 | Cite as

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
  • D. Elbourne


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%.

Key words

Neonate Intraventricular haemorrhage Fresh frozen plasma Gelatin Volume, expansion Randomized controlled trial 



confidence intervals


intraventricular haemorrhage


Northern Neonatal Nursing Initiative


Open study of infants at risk of or with respiratory insufficiency—the role of surfactant


relative risks


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Copyright information

© Springer-Verlag 1996

Authors and Affiliations

  • The Northern Neonatal Nursing Initiative [NNNI] Trial Group
  • D. Elbourne
    • 1
  1. 1.Perinatal Trials Service, National Perinatal Epidemiology UnitRadcliffe InfirmaryOxfordUK

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