Hydrocephalus in InfantsPhase 2NCT06693752
CEUS Evaluation of Hydrocephalus in Neonates and Infants
A Phase 2 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON] in people with Hydrocephalus in Infants and Hydrocephalus Acquired, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 minute to 18 months
- Conditions the study is for
- Hydrocephalus in Infants, Hydrocephalus Acquired
- What is being tested?
- Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Misun Hwang, MD, 267-425-7110, hwangm@chop.edu
Maria Mezher, MD, 267-425-5821, mezherm@chop.edu
About this study
Official title: Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound
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.
Read the detailed description
Contrast-enhanced ultrasound (CEUS) is a clinically used imaging technique that uses gas-filled microbubbles to enhance the visualization of blood vessels. Ultrasound contrast agents have been approved for use in Europe for around two decades, and in the United States, the FDA has approved the use of Lumason, a second-generation lipid/sulfur hexafluoride ultrasound contrast agent, for the evaluation of focal hepatic lesions, opacification of the left ventricular chamber of the heart and assessment of vesicoureteral reflux in pediatric patients. Unlike computed tomography or magnetic resonance imaging (MRI) contrast agents, ultrasound contrast agents have no associated renal toxicity and do not require ionizing radiation or sedation. The risk of adverse events is the lowest of all contrast agents available, with only minor adverse events reported in children, such as altered taste, tinnitus, light-headedness, and nausea.
Previous investigation on cerebral physiology in hydrocephalus has shown that increasing ventricular dilation results in reduced cerebral blood flow, as well as reduced cerebral oxygen saturation and higher oxygen extraction. These findings have been studied with currently available tools such as transcranial Doppler, MRI, and near infrared spectroscopy (NIRS).
However, there is no standardized tool for robust assessment of brain health in neonatal hydrocephalus. In this regard, prior work by the study team has shown a promising brain CEUS biomarker of ICP and brain ischemia in the porcine neonatal hydrocephalus model. Specifically, cerebral microvascular flows as measured using brain CEUS correlated with invasively measured ICP and brain ischemia. Therefore, there is a dire need to introduce better imaging tools such as CEUS to the clinical setting that can detect changes in ICP and brain ischemia in patients with hydrocephalus at an early stage and prompt therapeutic implementation/monitoring. The study seeks to validate first the safety and feasibility of performing brain CEUS in neonatal hydrocephalus.
Injection of Lumason contrast agent will be performed via the existing peripheral intravenous line or central line using the FDA-recommended dose of up to 0.03 mg/kg. Contrast-agent injection will be performed twice per CEUS scan to ensure image quality and test reproducibility. Two bolus injections will performed to evaluate for dynamic brain perfusion and several 2-minute cine clips as well as static images will be acquired during the exam.
Baseline and demographic characteristics will be summarized by standard descriptive statistics. Qualitative analysis will be performed by visual rating by 2 teams, blinded to clinical information, consisting of primary investigator and second radiologist (co-investigator). Each scan will be rated for diagnostic quality and qualitative rating of cranial perfusion. Quantitative analysis will be performed using time-intensity based analysis and the particle image and/or tracking velocimetry (PIV/PTV) method. These calculations will be performed after transferring the DICOM data obtained during the research procedure. The purpose is to utilize post-processing techniques available to the study team.
- Conditions
- Hydrocephalus in Infants, Hydrocephalus Acquired
- Being tested
- Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]
- Keywords
- Ultrasound, Contrast-enhanced ultrasound, Infant hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]Drug
Injection 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.
| Study group | Role | What they receive |
|---|---|---|
| Brain contrast-enhanced ultrasound | Experimental | The study duration per subject will be up to 30 minutes including the time to prepare the contrast agent, perform the pre-contrast imaging and the contrast-enhanced ultrasound (CEUS), as well as the 60-minute monitoring period after the administration of the contrast agent. A second CEUS exam may be performed within 1-2 weeks from the first scan for up to two CEUS exams of 1 hour and 30-minute duration each. Study participation will be complete when the 60-minute monitoring period of the last CEUS performed is complete. Receives: Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 2 years
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.
Measured: Up to 2 years
Secondary outcomes (6)
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
Correlation between contrast-enhanced ultrasound (CEUS) parameters (particle-tracking velocimetry) 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 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.
Measured: Up to 2 years
Correlation between contrast-enhanced ultrasound (CEUS) parameters (particle-image velocimetry) 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 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start30 Nov 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus in InfantsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Misun Hwang, MD, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693752
- Sponsor's protocol ID
- 24-022232
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound
- ClinicalTrials.gov ID
- NCT06693752
- Acronym / sponsor ID
- 24-022232
- Conditions
- Hydrocephalus in Infants, Hydrocephalus Acquired
- Keywords
- Ultrasound, Contrast-enhanced ultrasound, Infant hydrocephalus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Contrast-enhanced ultrasound (CEUS) is a clinically used imaging technique that uses gas-filled microbubbles to enhance the visualization of blood vessels. Ultrasound contrast agents have been approved for use in Europe for around two decades, and in the United States, the FDA has approved the use of Lumason, a second-generation lipid/sulfur hexafluoride ultrasound contrast agent, for the evaluation of focal hepatic lesions, opacification of the left ventricular chamber of the heart and assessment of vesicoureteral reflux in pediatric patients. Unlike computed tomography or magnetic resonance imaging (MRI) contrast agents, ultrasound contrast agents have no associated renal toxicity and do not require ionizing radiation or sedation. The risk of adverse events is the lowest of all contrast agents available, with only minor adverse events reported in children, such as altered taste, tinnitus, light-headedness, and nausea.
Previous investigation on cerebral physiology in hydrocephalus has shown that increasing ventricular dilation results in reduced cerebral blood flow, as well as reduced cerebral oxygen saturation and higher oxygen extraction. These findings have been studied with currently available tools such as transcranial Doppler, MRI, and near infrared spectroscopy (NIRS).
However, there is no standardized tool for robust assessment of brain health in neonatal hydrocephalus. In this regard, prior work by the study team has shown a promising brain CEUS biomarker of ICP and brain ischemia in the porcine neonatal hydrocephalus model. Specifically, cerebral microvascular flows as measured using brain CEUS correlated with invasively measured ICP and brain ischemia. Therefore, there is a dire need to introduce better imaging tools such as CEUS to the clinical setting that can detect changes in ICP and brain ischemia in patients with hydrocephalus at an early stage and prompt therapeutic implementation/monitoring. The study seeks to validate first the safety and feasibility of performing brain CEUS in neonatal hydrocephalus.
Injection of Lumason contrast agent will be performed via the existing peripheral intravenous line or central line using the FDA-recommended dose of up to 0.03 mg/kg. Contrast-agent injection will be performed twice per CEUS scan to ensure image quality and test reproducibility. Two bolus injections will performed to evaluate for dynamic brain perfusion and several 2-minute cine clips as well as static images will be acquired during the exam.
Baseline and demographic characteristics will be summarized by standard descriptive statistics. Qualitative analysis will be performed by visual rating by 2 teams, blinded to clinical information, consisting of primary investigator and second radiologist (co-investigator). Each scan will be rated for diagnostic quality and qualitative rating of cranial perfusion. Quantitative analysis will be performed using time-intensity based analysis and the particle image and/or tracking velocimetry (PIV/PTV) method. These calculations will be performed after transferring the DICOM data obtained during the research procedure. The purpose is to utilize post-processing techniques available to the study team.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain contrast-enhanced ultrasound | Experimental | Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]The study duration per subject will be up to 30 minutes including the time to prepare the contrast agent, perform the pre-contrast imaging and the contrast-enhanced ultrasound (CEUS), as well as the 60-minute monitoring period after the administration of the contrast agent. A second CEUS exam may be performed within 1-2 weeks from the first scan for up to two CEUS exams of 1 hour and 30-minute duration each. Study participation will be complete when the 60-minute monitoring period of the last CEUS performed is complete. |
Who may qualify
- Ages
- 1 minute to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]Injection 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. | Drug | Brain contrast-enhanced ultrasound |
Primary outcome
Feasibility of brain contrast-enhanced ultrasound (CEUS) examinations in infants with hydrocephalus
Time frame: Up to 2 years
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).
Safety of brain contrast-enhanced ultrasound (CEUS) examinations in infants with hydrocephalus
Time frame: Up to 2 years
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.
6 secondary outcomes
Correlation between contrast-enhanced ultrasound (CEUS) parameters (intensity perfusion) and invasively measured intracranial pressure (ICP) in infants with hydrocephalus
Time frame: Up to 2 years
Correlation between contrast-enhanced ultrasound (CEUS) parameters (particle-tracking velocimetry) and invasively measured intracranial pressure (ICP) in infants with hydrocephalus
Time frame: Up to 2 years
Correlation between contrast-enhanced ultrasound (CEUS) parameters (particle-image velocimetry) and invasively measured intracranial pressure (ICP) in infants with hydrocephalus
Time frame: Up to 2 years
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
Time frame: Up to 2 years
Correlation between contrast-enhanced ultrasound (CEUS) parameters (particle-tracking velocimetry) and cerebral ischemia biomarkers (lactate level and lactate/pyruvate ratio in cerebrospinal fluid) in infants with hydrocephalus
Time frame: Up to 2 years
Correlation between contrast-enhanced ultrasound (CEUS) parameters (particle-image velocimetry) and cerebral ischemia biomarkers (lactate level and lactate/pyruvate ratio in cerebrospinal fluid) in infants with hydrocephalus
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON] in people with Hydrocephalus in Infants and Hydrocephalus Acquired, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Misun Hwang, MD (267-425-7110, hwangm@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of brain contrast-enhanced ultrasound (CEUS) examinations in infants with hydrocephalus (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.