The Drainage, Irrigation and Fibrinolytic Trial for post-haemorrhagic hydrocephalus in newborn infants

The Drainage, Irrigation and Fibrinolytic Trial for post-haemorrhagic hydrocephalus in newborn infants: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN80286058

Enrollment

120

Registered

2005-09-08

Start date

2003-02-01

Completion date

Unknown

Last updated

2020-08-03

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

Conditions

Post-haemorrhagic ventricular dilatation Neonatal Diseases Post-haemorrhagic ventricular dilatation

Interventions

Drainage, irrigation and fibrinolytic therapy versus best standard therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infants of less than 28 days of age 2. Intraventricular haemorrhage 3. Progressive enlargement of ventricles to 4 mm over the 97th centile for width or 1 mm over the 97th centile for diagnonal, thalamo-occipital and third ventricle or enlargement of one ventricle together with midline shift

Exclusion criteria

Exclusion criteria: Generalised bleeding tendency

Design outcomes

Primary

Measure	Time frame
1. Ventriculoperitoneal shunt surgery 2. Disability at 2 years post-term	—

Secondary

Measure	Time frame
1. Secondary haemorrhage 2. Secondary central nervous system (CNS) infection 3. Death before 2 years post-term 4. Hospital admissions by 2 years of age	—

Countries

Norway, Poland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026