Patterns of cerebral oxygenation after ventricular reservoir placement and CSF removal: a pilot study
B
Beatrice Stefanescu
Primary Investigator
Enrolling By Invitation
32 weeks or below
All
Phase
N/A
5 participants needed
1 Location
Brief description of study
What is the purpose of this study?
About 25% of babies born prematurely (before 32 weeks gestation) develop brain bleeds (intraventricular hemorrhage or IVH), which could progress to the serious complication of post-hemorrhagic hydrocephalus (PHH). Infants with PHH may require neurosurgical intervention to relieve the increased pressure that builds up within the ventricles of the brain; currently the decision-making on timing for intervention is based on measurements detected by head ultrasound which indicate that damage has already been done within the brain. Thus, we propose a pilot study in collaboration with Washington University to develop and validate a non-invasive technique (utilizing near-infrared spectroscopy or NIRS) to detect early signs of hydrocephalus and response to treatment.
THIS STUDY IS ENROLLING BY INVITATION ONLY - The principal investigators and/or study team members will identify potential participants. Neurosurgery staff will also identify potential participants and notify the research team of individuals that receive a reservoir. Once the reservoir has been placed by the Neurosurgery team, the research team will be notified. The research team will screen the patient to confirm eligibility. Parents of eligible participants will be approached at the patient's bedside to assess interest in research projects.
Detailed description of study
What will happen during the study?
This is a two-center prospective observational study to examine the impact of removal of CSF via reservoir in neonatal patients with severe IVH on cerebral oxygenation. A Medtronic INVOS™ NIRS system will be utilized; this system has been FDA cleared for neonatal use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. The availability of specific neonatal probes and the non-invasive nature of commercial NIRS devices make them particularly well suited for use in both term and preterm neonates (30).
Patients will be enrolled as described in section 6.0 and observed for 4 weeks following ventricular reservoir surgery, or NICU hospital discharge, whichever happens sooner. We intend to enroll 10 patients at the Riley Hospital site, and 10 patients at the Washington University site.
A list of patients enrolled in this study will be shared with the Neurosurgical team. The Neurosurgery team member performing the taps will be asked to share what time they are planning on performing the next ventricular reservoir tap. Patients who are enrolled in the study will also have a sign at their bedside indicating this. Bedside nursing and the resident or Advanced Practice Provider (APP) caring for the patient will also be informed by study team members that the patient is enrolled in the study. Ideally, the plan to tap will be shared with the study team well in advance prior to the procedure via a Diagnotes secure chatroom. 1 hour prior to the procedure, bedside nursing or a study team member will connect the patient to a NIRS monitoring device. This device will remain in place throughout the procedure, and stay on for 2 hours once the tap is complete.
A training session will be provided by the study team and bedside nursing on utilization of the NIRS device, as it is not regularly utilized in the Riley Level IV NICU. Additional training sessions may be provided upon request, pending trainer availability.
Data will be recorded in REDCap including demographic information, perinatal and neonatal history, neurosurgical history, imaging results, and outcomes measures. Cerebral oxygenation values will be recorded at various timepoints that were obtained prior to, during, and after the tap.
Patients will be enrolled as described in section 6.0 and observed for 4 weeks following ventricular reservoir surgery, or NICU hospital discharge, whichever happens sooner. We intend to enroll 10 patients at the Riley Hospital site, and 10 patients at the Washington University site.
A list of patients enrolled in this study will be shared with the Neurosurgical team. The Neurosurgery team member performing the taps will be asked to share what time they are planning on performing the next ventricular reservoir tap. Patients who are enrolled in the study will also have a sign at their bedside indicating this. Bedside nursing and the resident or Advanced Practice Provider (APP) caring for the patient will also be informed by study team members that the patient is enrolled in the study. Ideally, the plan to tap will be shared with the study team well in advance prior to the procedure via a Diagnotes secure chatroom. 1 hour prior to the procedure, bedside nursing or a study team member will connect the patient to a NIRS monitoring device. This device will remain in place throughout the procedure, and stay on for 2 hours once the tap is complete.
A training session will be provided by the study team and bedside nursing on utilization of the NIRS device, as it is not regularly utilized in the Riley Level IV NICU. Additional training sessions may be provided upon request, pending trainer availability.
Data will be recorded in REDCap including demographic information, perinatal and neonatal history, neurosurgical history, imaging results, and outcomes measures. Cerebral oxygenation values will be recorded at various timepoints that were obtained prior to, during, and after the tap.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Intraventricular Hemorrhage, IVH, Riley
-
Age: 32 weeks or below
-
Gender: All
Inclusion Criteria
• Born before 32 weeks gestational age
• Admitted to one of the participating Level IV NICUs
• Diagnosis of severe IVH (defined as grade III/IV)
• History of ventricular reservoir device placement (or parental consent obtained for reservoir device) for treatment of post hemorrhagic hydrocephalus
Exclusion Criteria
• Known chromosomal anomaly
• Hemoglobinopathy (homozygous for hemoglobin S or C, α-thalassemia)
• Decision to discontinue life-sustaining treatment.
• Born before 32 weeks gestational age
• Admitted to one of the participating Level IV NICUs
• Diagnosis of severe IVH (defined as grade III/IV)
• History of ventricular reservoir device placement (or parental consent obtained for reservoir device) for treatment of post hemorrhagic hydrocephalus
Exclusion Criteria
• Known chromosomal anomaly
• Hemoglobinopathy (homozygous for hemoglobin S or C, α-thalassemia)
• Decision to discontinue life-sustaining treatment.
Updated on
29 Apr 2025.
Study ID: PNEO-WASHU-PHVD-NIRS, 21517
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