The Early v Late Ventricular Intervention Study (ELVIS)
Formerly known as the Post Haemorrhagic Intraventricular Treatment Trial (PHITT)
The DRIFT trial, the PHVD Drug Trial and the Ventriculomegaly Trial all failed to show that interventions reduced VP shunts in babies with Post-Haemorrhagic Ventricular Dilatation. It is now postulated that we, in UK, have all been intervening too late, when ventricular distention, distortion and oedema had gone too far to be reversed. Now a new international trial tests whether intervening at a lower threshold improves outcome in PHVD.
The entry criteria are:
IVH then enlargement to
Ventricular width >97th centile, but not >97th centile + 4 mm
AND diagonal >6 mm but not > 10 mm.
The infant is then randomised to:
EITHER Tapping CSF by lumbar puncture to prevent further enlargement or pressure with ventricular reservoir inserted if repeated taps are required
OR Observing without treatment and only starting to tap as above if and when the ventricular width is>4 mm over 97th centile and the diagonal is>10 mm.
Primary outcomes are
Shunt surgery or death
Secondary outcomes are
Secondary CSF Infection
Secondary Haemorrhage
Disability at 2 years
Full protocoluserfiles/file/ELVIS%20protocol%20short.doc
The trial originated with Prof Linda de Vries, Utrecht, and Dr Bert Smit, Rotterdam, Holland.
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In UK Contact: Prof Andrew Whitelaw 0117 959 5699
NICU, Southmead Hospital., Bristol
0117 959 5085 or 0117 959 5312 Andrew.Whitelaw@bristol.ac.uk
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