Randomised trial of prophylactic early fresh-frozen plasma or gelatin or glucose in preterm babies: outcome at 2 years. Northern Neonatal Nursing Initiative Trial Group.

BACKGROUND

Preterm babies are at risk of haemorrhagic and ischaemic brain injury. One controlled trial suggested that prophylactic fresh-frozen plasma (FFP) may reduce that risk but did not clarify whether the reduction in periventricular haemorrhage seen on ultrasonography was due to a haemostatic effect or stabilisation of intravascular volume by FFP. We undertook a trial of 776 babies of gestational age at birth less than 32 weeks to look at the short-term and long-term outcome after early prophylactic FFP.

METHODS

The defined primary trial outcome was survival without identifiable major disability 2 years after birth. The babies were randomly allocated, within 2 h of birth, 20 mL/kg FFP followed by a further 10 mL/kg after 24 h; or the same volumes of a gelatin-based plasma substitute; or maintenance infusion of glucose (control). The three groups were similar at trial entry. Outcome at discharge from hospital after birth (reported elsewhere) was similar in the three groups.

FINDINGS

No child was lost to follow-up, and all the surviving children underwent neurological and developmental assessment at the age of 2 years. The proportions dying (21.0%, 24.9%, 20.5%), and the proportions of survivors with a severe disability (11.3%, 11.2%, 14.1%) did not differ significantly between the randomised groups. The survivors had similar mean developmental quotients at age 2 (Griffiths' quotients 94, 97, and 95).

INTERPRETATION

This trial provides no evidence that the routine early use of FFP, or some other form of intravascular volume expansion, affects the risk of death or disability in babies born more than 8 weeks before term.