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NCT06693752
CEUS Evaluation of Hydrocephalus in Neonates and Infants
Conditions: Hydrocephalus in Infants, Hydrocephalus Acquired
Sex: All
Ages: 1 Minute – 18 Months
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Children's Hospital of Philadelphia
Location: Children's Hospital of Philadelphia Philadelphia Pennsylvania
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).
Source: ClinicalTrials.gov (NCT06693752). StuddyBuddy aggregates publicly available trial information.