New ultrasound technique could spare infants from invasive brain monitoring
NCT ID NCT06693752
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This study tests whether a special ultrasound with a contrast dye can safely and effectively measure brain health in infants with hydrocephalus, a condition where fluid builds up in the brain. About 20 infants under 1.5 years old will receive an injection of the contrast agent through an IV, followed by an ultrasound. The goal is to see if this method can replace or reduce the need for invasive pressure monitors and shunts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sulfur hexafluoride lipid-type A microspheres (contrast agent)
- What this could lead to
- If successful, this could lead to a safer, non-invasive way to monitor brain pressure and blood flow in infants with hydrocephalus, reducing reliance on invasive shunts.
- What could go wrong
- This is a small pilot study with only 20 infants, so results may not apply to all cases. The contrast agent also carries a small risk of allergic reactions or side effects.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
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 minute to 18 months
- 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. Males and females younger than 1.5 years old with diagnosed and/or suspected hydrocephalus. 2. Post menstrual age of 26 weeks or older. 3. Inpatients at the Children's Hospital of Philadelphia. 4. Parental/Legally authorized representative permission. Exclusion Criteria: 1. Medical history of Lumason hypersensitivity. 2. Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team. 3. Respiratory instability as defined by rapid escalation of respiratory support in the past 12-24 hours (Increased fraction of inspired oxygen (FiO2) requirement and/or nitric oxide).
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Conditions
The condition(s) this trial relates to.
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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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