Evaluating brain health in infants with hydrocephalus using ultrasound
Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound
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 |
| Enrollment | 20 (estimated) |
| Ages | 1 Minute to 18 Months |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06693752 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and children under 1.5 years old with diagnosed or suspected hydrocephalus.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.