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Khashu M, Balasubramaniam V. In neonates requiring intravascular volume resuscitation is the use of Gelofusine safe and efficacious? Arch Dis Child 2007;92:1037–8.
The authors appreciate concern raised by some colleagues with regard to the appropriateness of the third clinical bottom line “Weak evidence suggests an increased risk of necrotising enterocolitis with the use of Gelofusine in neonates” in this article and would like to retract the same. The authors agree that analysis 5.11 in the review by Osborn and Evans (Early volume expansion for prevention of morbidity and mortality in very preterm infants. Cochrane Database Syst Rev 2004;(2):CD002055) demonstrates no difference in incidence of necrotising enterocolitis (NEC) in infants treated with Gelofusine when compared to placebo. The authors also agree that the subgroup analysis 6.11 should be treated with caution (as the authors advise) as most likely it is related to multiple statistical analysis and these were not predefined secondary trial outcomes. However, we feel that caution should be exercised both ways. With current evidence any potential link between NEC and use of Gelofusine cannot be discounted. A query has been raised and this can only be answered by further research, pending which caution should be exercised in the use of Gelofusine, especially in preterm neonates. In conclusion, the authors agree that there is no clear evidence regarding increased risk of NEC with Gelofusine. However, a doubt regarding a potential link has been raised and evidence of harm cannot be excluded. Pending further research and safety studies, caution should be exercised in the use of Gelofusine in preterm neonates.
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