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Archives of Disease in Childhood 2007;92:1037-1038
Copyright © 2008 BMJ Publishing Group Ltd & Royal College of Paediatrics and Child Health

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In neonates requiring intravascular volume resuscitation is the use of gelofusine safe and efficacious?

erratum 92/11/1037

The authors appreciate concern raised by some colleagues with regard to the appropriateness of the clinical bottom line 3:
Weak evidence suggests an increased risk of NEC with the use of gelofuscine in neonates in the article: In neonates requiring intravascular volume resuscitation is the use of Gelofusine safe and efficacious? and would like to retract the same.
We agree that analysis 5.11 (*Osborn DA*, Evans N. Early volume expansion for prevention of morbidity and mortality in very preterm infants.
Cochrane Database of Syst Rev 2004,(2):CD002055) demonstrates no difference in incidence of NEC in infants treated with gelofusine when compared to placebo.We 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. Withcurrent 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 its use especially in preterm neonates.
In conclusion, we agree that there is no clear evidence regarding increased risk of NEC with gelofusine. However, a doubt regarding 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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