Elsevier

The Lancet

Volume 348, Issue 9022, 27 July 1996, Pages 229-232
The Lancet

Articles
Randomised trial of prophylactic early fresh-frozen plasma or gelatin or glucose in preterm babies: outcome at 2 years

https://doi.org/10.1016/S0140-6736(95)12506-XGet rights and content

Summary

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).

Section snippets

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.

Patients and methods

The Northern Regional Perinatal Mortality Coordinating Group3 commissioned a prospective region-wide collaborative study of outcome for all babies born before 32 weeks' gestation to mothers resident in the region in 1990–91; the study included a formal independent neurodevelopmental assessment of all survivors at the age of 2 years. To make the best of the opportunity provided by this geographically defined cohort study, several observational studies and two comparative trials of early nursing

Results

Recruitment began in January, 1990, and ended in May, 1992. We recruited 776 babies: 257 were allocated treatment with FFP, 261 treatment with gelatin plasma substitute, and 258 the glucose control. The random allocation was obtained by telephone, on average within 48 min of birth. There were no important differences between the groups at trial entry.4

There was some delay in initiation of treatment for 10% of the children allocated treatment with FFP (because of time for thawing), and 4% never

Discussion

Volume expansion is now widely used in the UK during the early management of preterm babies at birth, and many receive FFP or plasma protein fraction as part of the initial stabilisation routine.9, 10 This treatment seems to be given in the mistaken impression that low blood pressure necessarily threatens cerebral blood flow,11 that low blood pressure is usually due to a low intravascular volume,12, 13 and that volume expansion is an effective way of increasing blood pressure at birth.4, 9 None

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