Acta paediatrica
-
To evaluate whether paediatric randomized clinical trials (RCTs) adopt recent guidance on Data Monitoring Committees (DMCs), interim analysis and early termination. ⋯ Few paediatric trials report on DMCs' roles, interim analysis or early stopping. Heterogeneous practices and apparent shortcomings jeopardize the validity of trial results. Easily accessible guidelines for the design, conduct and reporting of paediatric DMCs are needed.
-
Neonatal hypoxic-ischaemic encephalopathy (HIE), if severe, may involve cerebral vasoparalysis. In HIE, Pourcelot's cerebral vascular resistance index (RI) below 0.55 (by Doppler ultrasound) from published literature at normothermia predicted poor outcome with a positive predictive value (PPV) of 84%. The aim of this study was to re-assess RI as a predictor of outcome in HIE during hypothermia. ⋯ Low RI is significantly less predictive of poor outcome during hypothermia than normothermia. The lower PPV may be because hypothermia affects cerebral vasculature or protects the brain solely at a molecular and cellular level. Infants, who would have been predicted from their RI to have poorer outcome at normothermia, have better outcome when cooled.