ArticlesRandomised trial of prophylactic early fresh-frozen plasma or gelatin or glucose in preterm babies: outcome at 2 years
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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Cited by (0)
Study organisation and participants listed at end of paper