MULTICENTRE TRIAL OF ETHAMSYLATE FOR PREVENTION OF PERIVENTRICULAR HAEMORRHAGE IN VERY LOW BIRTHWEIGHT INFANTS
1986; Elsevier BV; Volume: 328; Issue: 8519 Linguagem: Inglês
10.1016/s0140-6736(86)91432-7
ISSN1474-547X
AutoresJohnW.T Benson, Christine Hayward, J P Osborne, JaneF Schulte, MarkR Drayton, JohnF Murphy, J Rennie, BrianD. Speidel, RichardW.I. Cooke,
Tópico(s)Neuroscience of respiration and sleep
ResumoThe effectiveness of ethamsylate in the prevention of periventricular haemorrhage (PVH) in very low birthweight infants was evaluated by means of a multicentre, placebo-controlled, double-blind trial. In 330 infants without evidence of PVH on initial cranial ultrasound examination there was little difference between ethamsylate and placebo groups with respect to subependymal haemorrhage, but intraventricular and parenchymal haemorrhages developed in 30/162 infants (18.5%) in the treated group, compared with 50/168 (29.8%) in the control group (p<0.02). The incidence of intraventricular and parenchymal haemorrhage in survivors was 20/137 (14.6%) in the ethamsylate group and 37/146 (25.3%) in the controls (p<0.05). In 30 infants with evidence of PVH on the initial scan, ethamsylate treatment seemed to limit parenchymal extension. Analysis of the total cohort of 360 infants showed that the proportion of infants in whom an increase of two or more grades of severity of PVH was recorded during the trial was lower in the treated than in the placebo group (p<0.01). No adverse effects were attributed to ethamsylate therapy. The reported incidence of patent ductus arteriosus was lower in the treated than in the placebo group (p<0.02). Mortality was similar in the two groups.
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