1. Prematurity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Premature infants with a gestational age equal to or below 34 weeks; 2. With an intraventricular haemorrhage grade III according to Volpe (> 50 % of the ventricle); and 3. With 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.
Exclusion criteria
Exclusion criteria: 1. Congenital cerebral malformation; 2. Cerebral parenchymal haemorrhage; 3. Periventricular leucomalacia > grade II according to de Vries; 4. Posthaemorrhagic ventricular dilatation already present at birth; 5. Central nervous system infection; 6. Metabolic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need of ventriculoperitoneal shunt. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurodevelopmental outcome on the Bayley Scales of Infant Development at 24 months corrected age, assessed by a ‘blinded’ developmental psychologist. Number of (lumbar) punctures, reservoirs, reservoir dysfunctions, reservoir infections and reservoir revisions, drains, drain dysfunctions, drain infections and drain revisions. | — |
Contacts
Erasmus Medical Center, P.O. Box 2060