NCT06693752 CEUS Evaluation of Hydrocephalus in Neonates and Infants
| NCT ID | NCT06693752 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Hydrocephalus in Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-05-05 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hydrocephalus affects up to 2 out of every 500 births and results in long-term disability in up to 78% of those affected. The standard treatment of hydrocephalus is cerebrospinal fluid (CSF) diversion via placement of an invasive ventricular shunt to relieve elevated intracranial pressure (ICP). The clinical decision for CSF diversion is based on the ventricular size and clinical symptoms which are not robust indicators of brain health in neonatal hydrocephalus. The purpose of this study is to assess the safety and feasibility of performing brain contrast-enhanced ultrasound (CEUS) in neonates and infants with diagnosed and/or suspected hydrocephalus.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06693752 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 18 Months, studying Hydrocephalus in Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06693752 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06693752 currently recruiting?
Yes, NCT06693752 is actively recruiting participants. Contact the research team at hwangm@chop.edu for enrollment information.
Where is the NCT06693752 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06693752 clinical trial?
NCT06693752 is sponsored by Children's Hospital of Philadelphia. The trial plans to enroll 20 participants.