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A multicentre randomised controlled trial of low versus high threshold treatment in preterm infants with progressive posthaemorrhagic ventricular dilatation.

A multicentre randomised controlled trial of low versus high threshold treatment in preterm infants with progressive posthaemorrhagic ventricular dilatation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20414
Enrollment
125
Registered
2005-08-29
Start date
2006-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Prematurity

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
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. Punctu

Sponsors

Neonatology Intensive Care department Erasmus MC- Sophia Children’s Hospital
Lead Sponsor

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

MeasureTime frame
Need of ventriculoperitoneal shunt.

Secondary

MeasureTime 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

Public ContactB.J. Smit

Erasmus Medical Center, P.O. Box 2060

b.j.smit@erasmusmc.nl+31 (0)10 4636363

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)