Evaluating brain health in infants with hydrocephalus using ultrasound
Official title: Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound
Run by Children's Hospital of Philadelphia · NCT06693752 · Data updated 2026-11-12
This study is testing a new ultrasound method to see if it can safely check brain health in babies with hydrocephalus.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Minute to 18 Months |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | November 30, 2026 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2028 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06693752 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants and children under 1.5 years old with diagnosed or suspected hydrocephalus.
✕Probably not a fit
Patients with a history of hypersensitivity to Lumason or those experiencing recent hemodynamic or respiratory instability may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety and feasibility of using contrast-enhanced ultrasound (CEUS) to evaluate brain health in neonates and infants diagnosed with or suspected of having hydrocephalus. CEUS utilizes gas-filled microbubbles to enhance the visualization of blood vessels without the risks associated with other imaging techniques, such as radiation exposure or renal toxicity. The study will involve administering a specific ultrasound contrast agent, Lumason, to eligible participants and monitoring their brain health indicators. The goal is to establish a standardized tool for assessing brain health in this vulnerable population.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective method for monitoring brain health in infants with hydrocephalus, potentially improving treatment outcomes.
How similar studies have gone: While CEUS has been used in other contexts, this specific application in neonatal hydrocephalus is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Misun Hwang, MD
- Email: hwangm@chop.edu
- Phone: 267-425-7110
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.