ELVIS

The Early v Late Ventricular Intervention Study (ELVIS)

A randomised trial of low versus high threshold treatment in preterm infants with post-haemorrhagic ventricular dilatation

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

Image of baby brain

Graph and scan of baby brain

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

Consent form           Information for parents

 

The trial originated with Prof Linda de Vries, Utrecht, Holland.

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In UK Contact: Prof Andrew Whitelaw 0117 959 5085 or 5699

NICU, Southmead Hospital., Bristol

0117 959 5085 or 0117 959 5312                         Andrew.Whitelaw@bristol.ac.uk