Endoscopic lavage after intraventricular haemorrhage in neonates in the UK: a national randomised controlled trial on the efficacy of neuro-endoscopic lavage

Not Applicable

• Conditions: Intraventricular Haemorrhage (IVH) and Post-haemorrhagic Ventricular Dilatation (PHVD) in premature infants born before 37 weeks of gestational age; Pregnancy and Childbirth

• Registration Number: ISRCTN14018410
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 3 June 2024
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Premature infants born before 37 weeks of gestational age
2. IVH: Papile Grades II-IV on cranial ultrasound scan
3. PHVD: Ventricular index at or beyond the threshold point of the 97th centile for gestational age plus 4 mm on the Levene chart despite 2 attempted lumbar or ventricular punctures.

Exclusion Criteria

1. Infants with coagulopathy (INR > 1.6) or platelet disorders (platelet count under 80,000/mL) that persist on attempted correction. Clinical judgement will be made by the Investigator.
2. Infants deemed too unstable for neurosurgical intervention. This is a clinical judgement made by the responsible neurosurgeon, neonatologist and anaesthetic team.
3. Parents or carers unwilling to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified