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

• Conditions: 1. Prematurity; 2. Intraventricular haemorrhage grade III (> 50 % of the ventricle); 3. 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.

• Registration Number: NL-OMON20414
• Lead Sponsor: eonatology Intensive Care departmentErasmus MC- Sophia Children’s Hospital

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 125

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

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