Inpatient- Pediatric

PI: Strahle

Protocol ID: 201606086

Short study title: CSF Biomarkers in Treatment of Shunt Infection

Short description: The purpose of this study is to understand the evolution of CSF microbiota over time during treatment for shunt infection. CSF will be collected then shipped to an external lab for analysis.

Key eligibility criteria:

• Any sex, any age
• Patients undergoing treatment for shunt infection with reservoir, EVD, subgaleal shunt, ETV

Contact person: Diego Morales, 314-454-4688, d.morales@wustl.edu

Enrollment period: Current

PI: Strahle

Protocol ID: 201908133

Short study title: Endoscopic versus Shunt Treatment for Hydrocephalus in Infants

Short description: Multi-center (16 sites) RCT comparing ETV+CPC and shunt in infants with hydrocephalus. ETV+CPC offers the potential for shunt-freedom but the cognitive outcome of ETV+CPC is not known in this patient population. The goal of this study is to compare the 2 surgeries in a randomized fashion and to correlate with neurodevelopmental outcomes (Bayley III cognition, language, and motor), brain volumes, fractionated anisotropy in white matter tracts, and CSF markers.

Key eligibility criteria:

• Any sex, age < 52 weeks corrected age
• Hydrocephalus requiring treatment

Contact person: Diego Morales, 314-454-4688, d.morales@wustl.edu

Enrollment period: Current

PI: Strahle

Protocol ID: 201101887

Short study title: Characterization of Discarded CSF in Ventricular Taps

Short description: The goal of this study is to identify potential biomarkers that may aid in determining the optimal timing of intervention for infants with PHH. CSF that would otherwise be discarded will be collected for proteomic analysis.

Key eligibility criteria:

• Any sex, age 5 years and younger
• Patient has ventricular access device and will undergo taps as clinically indicated
• Preterm infants without PHVD undergoing LPs for sepsis evaluation with subsequent negative CSF culture

Contact person: Diego Morales, 314-454-4688, d.morales@wustl.edu

Enrollment period: August 2010 – current

PI: Strahle

Protocol ID: 201203151

Short study title: CSF Bank for Pediatric Neurosurgery

Short description: The goal of this study is to collect all CSF specimen collection under one central banking protocol. This will include any CSF obtained from any surgical intervention, lumbar puncture (LP), external reservoir tapping, or other procedures related to Discarded CSF (i.e. SLCH Laboratory LP samples). Processed specimens will be stored and available for future research studies. This will help us and other external institutions advance the knowledge of any CSF questions pertaining to a wide array of injuries or diseases.

Key eligibility criteria:

• Any sex, any age
• Any procedure or surgery done where CSF might be attained and would be discarded otherwise.

Contact person: Diego Morales, 314-454-4688, d.morales@wustl.edu

Enrollment period: 2012 – current

PI: Roland

Protocol ID: 202406138

Short study title: Assessment of Flow in Cerebrospinal Fluid Shunts with a Second Generation Wireless Thermal Anisotrophy Measurement Device

Short description: This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess the flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.

Key eligibility criteria:

• Any sex, any age
• Diagnosis of congenital hydrocephalus
• Patient scheduled to undergo surgery for hydrocephalus with an implanted ventriculoperitoneal shunt that is potentially malfunctioning.

Contact person: Diego Morales, 314-454-4688, d.morales@wustl.edu

Enrollment period: Current

PI: Strahle

Protocol ID: 201011763

Short study title: Advanced MR Imaging in Preterm Infants with IVH and PHVD

Short description: There is a lack of useful short-term outcome measures in predicting outcome in preterm infants with IVH and PHVD. The goal of this study is to use advanced MRI techniques such as DTI and resting state fMRI to evaluate white matter integrity and cortical development as noninvasive biomarkers in addition to standard of care with cranial ultrasound.

Key eligibility criteria:

• Any sex, age 5 years and younger
• Diagnosis of germinal matrix hemorrhage-intraventricular hemorrhage and PHVD
• Ideally patients should be identified at the time of diagnosis and followed through progression and treatment of PHVD

Contact person: Diego Morales, 314-454-4688, d.morales@wustl.edu

Enrollment period: Current

PI: Strahle

Protocol ID: 201103136

Short study title: Pediatric Neurosurgery Tissue Bank

Short description: The purpose of the Pediatric Neurosurgery Tissue Bank is to collect and store tissue samples from patients undergoing surgery. These samples include benign and malignant brain/spine tumors, normal/abnormal brain tissue, cerebrospinal fluid (CSF), bone, blood samples, and other related tissues. Specimens will be collected from the operating room or specialized procedure room in which said tissue is removed. Biological parents and siblings are also eligible to donate blood samples. Data from this tissue bank will be used to better understand disease progression, disease biology, generate realistic animal models of disease, and help to develop newer therapies.

Protocol ID: 202002124

Key eligibility criteria:

• Any sex, any age
• Patients scheduled to undergo surgical resection for brain/spinal tumor, seizure focus, or brain malformation
• Biological parents and siblings are also eligible to donate blood samples
• Patients at end-of-life are eligible to participate through the Legacy Brain Donation Program

Contact person: Corrine Gardner, 314-454-2792, gardnerc@wustl.edu

Enrollment period: Current

PI: Strahle

Protocol ID: 202401143

Short study title: Amniotic Fluid & CSF Factors Responsible for Hydrocephalus and Altered Brain Development in Myelomeningocele.

Short description: Up to 85% of children born with myelomeningocele (MMC)develop hydrocephalus. The origin of this hydrocephalus is not known and there have been no large-scale preclinical studies addressing the mechanisms of this type of hydrocephalus. During MMC the amniotic fluid (AF) becomes in contact with important neurodevelopmental cells. Even though this occurs, here have been no studies evaluating the consequences of AF exposure to the cerebrospinal fluid (CSF) and developing brain. We propose to analyze the AF and CSF in the control setting and the MMC setting to compare their contents. Successful completion of the study will determine the role of AF in ventricular expansion, CSF flow and the development of hydrocephalus, with identification of specific targets to interrupt the origin of hydrocephalus in children with MMC.

Key eligibility criteria:

• Pregnant mothers undergoing a fetal operation

Contact person: Diego Morales, 314-454-4688, d.morales@wustl.edu

Enrollment period: Current