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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]
DrugInjection of Sulfur hexafluoride lipid-type A microspheres contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg before performing the contrast-enhanced ultrasound. The weight-based dose of 0.03 mL per kg will be repeated one time during a single examination. Following each injection, an intravenous flush of 0.9% Sodium Chloride is injected.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Brain contrast-enhanced ultrasoundExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of brain contrast-enhanced ultrasound (CEUS) examinations in infants with hydrocephalus
Total number and percentage of successfully competed brain CEUS with adequate quality. Sufficient quality to be interpreted by radiologists without significant motion degradation and/or obscuration due to poor acoustic penetration. Visual rating by 2 teams consisting of primary investigator and second radiologist (co-investigator). Each scan will be rated for diagnostic quality and qualitative rating of cranial perfusion. The visual rating scale used will be: 0 (absent flow), 1 (decreased flow), 2 (normal flow), 3 (increased flow).
Time frame
Up to 2 years2
Safety of brain contrast-enhanced ultrasound (CEUS) examinations in infants with hydrocephalus
Total number/percentage of patients who experienced adverse events (if any) will be reported to assess safety. All subjects entered into the study and receiving at least one injection of investigational drug will be included in the safety analysis. Adverse events will be recorded at 1) 60 minutes post-scanning when the monitoring period is completed, and 2) through 48 hours post-scanning, with documentation at 48 hours post-scanning if no adverse event presents until this point.
Time frame
Up to 2 yearsSecondary outcomes
1
Correlation between contrast-enhanced ultrasound (CEUS) parameters (intensity perfusion) and invasively measured intracranial pressure (ICP) in infants with hydrocephalus
Pearson's or Spearman's correlation coefficients will be calculated to measure the relationship between CEUS parameters and ICP measurements. The investigators will analyze blood flow intensity perfusion as the first CEUS parameter. The correlation values will range from -1 to +1, where positive values indicate measurements increase together, negative values indicate one increases as the other decreases, and values closer to ±0.5 suggest strong relationships. The choice between Pearson's or Spearman's correlation will depend on whether the data follows a normal distribution pattern.
Time frame
Up to 2 years2
Correlation between contrast-enhanced ultrasound (CEUS) parameters (particle-tracking velocimetry) and invasively measured intracranial pressure (ICP) in infants with hydrocephalus
Pearson's or Spearman's correlation coefficients will be calculated to measure the relationship between CEUS parameters and ICP measurements. The investigators will analyze particle-tracking velocimetry as the second CEUS parameter. The correlation values will range from -1 to +1, where positive values indicate measurements increase together, negative values indicate one increases as the other decreases, and values closer to ±0.5 suggest strong relationships. The choice between Pearson's or Spearman's correlation will depend on whether the data follows a normal distribution pattern.
Time frame
Up to 2 years3
Correlation between contrast-enhanced ultrasound (CEUS) parameters (particle-image velocimetry) and invasively measured intracranial pressure (ICP) in infants with hydrocephalus
Pearson's or Spearman's correlation coefficients will be calculated to measure the relationship between CEUS parameters and ICP measurements. The investigators will analyze particle-image velocimetry as the third CEUS parameter. The correlation values will range from -1 to +1, where positive values indicate measurements increase together, negative values indicate one increases as the other decreases, and values closer to ±0.5 suggest strong relationships. The choice between Pearson's or Spearman's correlation will depend on whether the data follows a normal distribution pattern.
Time frame
Up to 2 years4
Correlation between contrast-enhanced ultrasound (CEUS) parameters (intensity perfusion) and cerebral ischemia biomarkers (lactate level and lactate/pyruvate ratio in cerebrospinal fluid) in infants with hydrocephalus
Pearson's or Spearman's correlation coefficients will be calculated to measure the relationship between CEUS parameters and blood markers that indicate brain tissue damage due to reduced blood flow (cerebral ischemia biomarkers). The investigators will analyze blood flow intensity perfusion as the first CEUS parameter. The correlation values will range from -1 to +1, where positive values indicate measurements increase together, negative values indicate one increases as the other decreases, and values closer to ±0.5 suggest strong relationships. The choice between Pearson's or Spearman's correlation will depend on whether the data follows a normal distribution pattern.
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov