CEUS Evaluation of Hydrocephalus in Neonates and Infants
This study is looking at a new way to evaluate hydrocephalus (a buildup of fluid in the brain) in babies and young children. It uses a special type of ultrasound called contrast-enhanced ultrasound (CEUS) with a contrast agent called Sulfur Hexafluoride Lipid Type A Microspheres (LUMASON). This agent helps doctors see blood vessels more clearly. The main goals are to see if this imaging method is safe and practical to use for infants with hydrocephalus. You might be able to join if you are a baby or child under 18 months old, are at Children's Hospital of Philadelphia, and have diagnosed or suspected hydrocephalus. The study is currently unclear about its recruitment status and plans to enroll 20 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment or intervention. It plans to enroll 20 participants.
- What's involved
- Participants will receive an injection of Sulfur Hexafluoride Lipid Type A Microspheres (LUMASON) through an existing IV line before a contrast-enhanced ultrasound.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and feasibility of the brain CEUS examinations for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CEUS Evaluation of Hydrocephalus in Neonates and Infants
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Feasibility of brain contrast-enhanced ultrasound (CEUS) examinations in infants with hydrocephalusUp to 2 years
Total number and percentage of successfully competed brain CEUS with adequate quality. Sufficient quality to be interpreted by radiologists without significant motion degradation and/or obscuration due to poor acoustic penetration. Visual rating by 2 teams consisting of primary investigator and second radiologist (co-investigator). Each scan will be rated for diagnostic quality and qualitative rating of cranial perfusion. The visual rating scale used will be: 0 (absent flow), 1 (decreased flow), 2 (normal flow), 3 (increased flow).
- Safety of brain contrast-enhanced ultrasound (CEUS) examinations in infants with hydrocephalusUp to 2 years
Total number/percentage of patients who experienced adverse events (if any) will be reported to assess safety. All subjects entered into the study and receiving at least one injection of investigational drug will be included in the safety analysis. Adverse events will be recorded at 1) 60 minutes post-scanning when the monitoring period is completed, and 2) through 48 hours post-scanning, with documentation at 48 hours post-scanning if no adverse event presents until this point.