Neuroendoscopic Lavage in the Management of Neonatal Intra-ventricular Hemorrhage (NCT07733778) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neuroendoscopic Lavage in the Management of Neonatal Intra-ventricular Hemorrhage
30 participantsStarted 2026-08-01
Plain-language summary
Neonatal intraventricular hemorrhage (IVH) is a major cause of morbidity and mortality in premature infants and is frequently associated with post-hemorrhagic ventricular dilatation (PHVD) and hydrocephalus. Neuroendoscopic lavage (NEL) is a minimally invasive technique that allows removal of intraventricular blood clots and inflammatory debris, potentially reducing cerebrospinal fluid pathway obstruction and the need for permanent cerebrospinal fluid diversion. This prospective interventional study aims to evaluate the safety, feasibility, and clinical outcomes of neuroendoscopic lavage in neonates with IVH-related hydrocephalus. Patients will be assessed clinically and radiologically before and after the procedure, with follow-up focusing on ventricular size, shunt dependency, procedure-related complications, and neurological outcomes.
Who can participate
Age range
1 Day – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Neonates aged 28 days or less at the time of presentation.
. Neonates diagnosed with severe IVH with ventricular dilatation (Grade III or IV on Papile classification).
. Written informed consent obtained from parents or legal guardians -
Exclusion criteria
. Grade I or Grade II intra-ventricular hemorrhage according to the Papile classification.
. Major congenital brain malformations, like Dandy-Walker malformation and Holoprosencephaly or severe congenital anomalies incompatible with life.
. Neonates with active central nervous system infection (meningitis or ventriculitis).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of PHVD and permanent VP shunt insertion within the follow-up period after neuro-endoscopic lavage