CEUS Evaluation of Hydrocephalus in Neonates and Infants
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-18
SponsorChildren's Hospital of Philadelphia
About this trial
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
Qualifiers
Males and females younger than 1.5 years old with diagnosed and/or suspected hydrocephalus.
Post menstrual age of 26 weeks or older.
Inpatients at the Children's Hospital of Philadelphia.
Parental/Legally authorized representative permission.
Disqualifiers
Medical history of Lumason hypersensitivity.
Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team.
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).
Trial design
Treatments tested in this trial
- Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov