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

Completed

• Conditions: Posthaemorrhagic ventricular dilatation; Pregnancy and Childbirth; Intracranial nontraumatic haemorrhage of fetus and newborn

• Registration Number: ISRCTN43171322
• Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29440132

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-27
• Study Completion: 2014-01-01
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Current inclusion criteria as of 03/01//2012
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

Previous inclusion criteria
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)
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

Exclusion Criteria

Current exclusion criteria as of 03/01//2012
1. Congenital cerebral malformation
2. Periventricular leucomalacia > grade II according to de Vries
3. Posthaemorrhagic ventricular dilatation already present at birth
4. Central nervous system infection
5. Metabolic disease

Previous 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified