ISRCTN43171322.

Trial name or title	A multicentre randomised controlled trial of low versus high threshold treatment in preterm infants with progressive posthaemorrhagic ventricular dilatation (PHVD)
Methods	The infants are randomly allocated to the low threshold group or the high threshold group. Those in the low threshold group are treated when the ventricles reach a lower size threshold compared with the high threshold group. Treatment consists of lumbar punctures, where a needle is inserted into the lower part of the spine to drain fluid. If lumbar punctures are still needed over 28 days after the first one, a shunt is inserted into the brain to drain fluid. The two groups are compared with regard to how many infants need a shunt and their brain development at two years of age.
Participants	Premature infants with: 1. A gestational age equal to or below 34 weeks 2. An intraventricular haemorrhage grade III according to Volpe (>50% of the ventricle) and grade IV haemorrhage 3. A progressive posthaemorrhagic ventricular enlargement above the 97th centile for gestational age according to Levene and a diagonal width enlargement of the frontal horn above 6 mm according to Davies
Interventions	Comparison: low threshold versus high threshold intervention. Low threshold: intervention when an increase in ventricular width according to Levene above the 97th centile towards the P97 + 4 but without crossing the >P97 + 4 and an increase in diagonal width according to Davies above 6 mm towards 10 mm, but not above 10 mm. High threshold: intervention after an increase in ventricular width according to Levene above the P97 + 4 and an increase in diagonal width according to Davies above 10 mm. Intervention: Lumbar punctures (LP; 10 ml/kg) on 2 days. Cranial ultrasound is repeated daily. If on the third day a LP is still required, a subcutaneous reservoir will be inserted. Daily 10 cc/kg will be drained in 2 taps a day. Punctures from the reservoir will be continued over the next days or weeks. The amount of CSF drained will be increased or decreased in order to reach and keep the ventricular index according to Levene <P97 and diagonal anterior horn width <6 mm. If punctures are still necessary exceeding 28 days after the first LP, a ventriculoperitoneal shunt is inserted. If the bodyweight of the infant is less than 2.5 kg, the insertion of the shunt will be postponed until the bodyweight is over 2.5 kg, if CSF drainage is still needed then.
Outcomes	Primary: Need for ventriculoperitoneal shunt Secondary: 1. Neurodevelopmental outcome on the Bayley Scales of Infant Development at 24 months corrected age, assessed by a ‘blinded’ developmental psychologist 2. Number of (lumbar) punctures, reservoirs, reservoir dysfunctions, reservoir infections and reservoir revisions, drains, drain dysfunctions, drain infections and drain revisions
Starting date	January 27, 2006
Contact information	LS de Vries MD, PhD, l.s.devries@umcutrecht.nl
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