Can a gentle brain washout save newborns from a lifetime shunt?
NCT ID NCT07733778
First seen Jul 29, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This trial tests whether a minimally invasive procedure called neuro-endoscopic lavage can safely remove blood clots from the brains of newborns with severe intraventricular hemorrhage. The goal is to see if this washout can prevent permanent fluid buildup and the need for a lifelong brain shunt. Thirty infants under 28 days old with the most severe bleeding grades will be enrolled and followed for complications and neurological outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- neuro-endoscopic lavage (a minimally invasive procedure to wash out blood clots from the brain using saline)
- What this could lead to
- If effective, this procedure could reduce the need for permanent brain shunts in newborns with severe intraventricular hemorrhage, potentially improving long-term outcomes.
- What could go wrong
- This is a small, early-stage study with only 30 participants, so results may not apply broadly. The procedure carries risks such as infection, bleeding, or brain injury in fragile newborns.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day to 28 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Neonates aged 28 days or less at the time of presentation. 2. Neonates diagnosed with severe IVH with ventricular dilatation (Grade III or IV on Papile classification). 3. Written informed consent obtained from parents or legal guardians - Exclusion Criteria: 1. Grade I or Grade II intra-ventricular hemorrhage according to the Papile classification. 2. Major congenital brain malformations, like Dandy-Walker malformation and Holoprosencephaly or severe congenital anomalies incompatible with life. 3. Neonates with active central nervous system infection (meningitis or ventriculitis). 4. Severe coagulopathy not correctable before surgery. 5. Refusal of parental or legal guardian consent
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.