NIRS Monitoring in Premature Infants

Learn more about:
Related Clinical Trial
EVD Drainage Data and Intracranial Pressure (ICP) Measurements Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar Assessment of CSF Shunt Flow With Thermal Measurements B The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus: A Pilot Study Quantitative Pupillometry Pilot Study to Evaluate the CereVasc® eShunt® System US Pilot Study to Evaluate the CereVasc® eShunt® System Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation Combined Flow and Pressure Study of Craniospinal Dynamic Assessment of CSF Shunt Flow With Thermal Measurements Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)? Brain Aneurysms: Utility of Cisternal Urokinase Irrigation Three-step Disinfection Reduce the Postoperative Infection Rate of Ventriculoperitoneal Shunt Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ? Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients’ Treatment Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage Bactiseal Catheter Safety Registry in China Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement Hyperfine Portable MRI in Hydrocephalus Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries An Evaluation of a Non-invasive Brain Monitor An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device Assess Specific Kinds of Children Challenges for Neurologic Devices Study A Secondary Study Evaluating Aqueduct’s Smart External Drain (SED) Simulation Efficacy in Neurosurgical Education Intraoral 30% Glucose Effect In Newborns The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter Subgaleal Drains in Decompressive Craniectomies Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage A Study Evaluate Aqueduct’s Smart External Drain Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters Study of Ultrasound of the Eye for Children With Suspected Shunt Failure MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage Brain Ultrasound in the Weaning of External Ventricular Leads A Study on the Safety of Hakim Programmable Shunt System Thermal Camera Detection of Ventriculoperitoneal Shunt Flow Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability NIMIP: Non Invasive Measurement of the Intracranial Pressure Linking Digital Smartphone Behaviour With Brain Function Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains. Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement–Celda Infusion Subprotocol Strata Programmable CSF Shunt Valve Study The CSF Shunt Entry Site Trial Guided Application of Ventricular Catheters Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus CRT ShuntCheck “Fit & Function” Study Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk NIRS Monitoring in Premature Infants Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients Isoflurane-induced Neuroinflammation in Children With Hydrocephalus Hydrocephalus iPad-App Based Intervention Study Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus A Study Comparing Two Treatments for Infants With Hydrocephalus A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology Study of Choroid Plexus Cauderization in Patients With Hydrocephalus ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus BIS Monitoring of Patients With Hydrocephalus Magnetic Resonance Elastography in Hydrocephalus Noninvasive Intracranial Pressure and Hydrocephalus Patients Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Brief Title

NIRS Monitoring in Premature Infants

Official Title

Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus

Brief Summary

      This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation
      spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral
      oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular
      hemorrhage (GM-IVH) and/or post-hemorrhagic hydrocephalus (PHH) in comparison to newborns
      with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize
      that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH
      severity and response to PHH treatment.

      This is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved,
      multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth
      Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National
      Institute of Health (NIH) to support the study and is the overall principal Investigator (PI)
      overseeing the study.
    

Detailed Description

      Introduction and specific aims:

      Germinal matrix-intraventricular hemorrhage (GM-IVH) occurs in 45% of extremely low birth
      weight (ELBW) premature infants, often leading to long-term neurodevelopmental impairments
      (NDI). Post-hemorrhagic hydrocephalus (PHH) is a common complication of GM-IVH and increases
      the risk of major NDI to 75-90%. Currently, the only bedside tool to assess for hemorrhage
      and monitor for secondary hydrocephalus is ultrasound. Although increasing ventricular size
      is currently used to determine need for intervention, measures based on cerebral physiology
      are needed to better determine the impact of the expanding ventricles on individual cerebral
      metabolism.

      Our group has developed advanced FDNIRS-DCS technology for monitoring cerebral oxygen
      metabolism (CMRO2) in newborns at the bedside. We hypothesize that baseline and evoked
      cerebral metabolic dysfunctions are better biomarkers for GM-IVH and PHH severity and
      response to PHH treatment. To test our hypotheses, we will address the following specific
      aims:

      Aim 1: Determine post-natal cerebral hemodynamics and oxygen metabolism trajectories in
      GM-IVH and PHH neonates with respect to normal controls and differences between PHH infants
      and infants affected by hydrocephalus due to other pathologies.

      We hypothesize that:

        1. Infants with GM-IVH have lower CBF and CMRO2 than healthy controls and the decrease is
           in proportion to the severity of GM-IVH. (GM-IVH vs HC)

        2. Infants with PHH have lower CBF and CMRO2 than healthy controls. (PHH vs HC)

        3. For infants who developed PHH, the decrease of CBF and CMRO2 is affected by both
           hemorrhages and the severity of hydrocephalus. (PHH vs VC)

      Aim 2: Test the efficacy of cerebral hemodynamics and metabolism in detecting hydrocephalus
      treatment response in both PHH and VC groups.

      We hypothesize that CBF and CMRO2 increase in response to treatment-associated improvements
      in hydrocephalus but remain depressed when response to treatment is inadequate.

      Aim 3: Test the sensitivity of FDNIRS-DCS measured cerebral hemodynamics and oxygen
      metabolism in predicting developmental outcomes in infants with GM-IVH and PHH. We will
      assess neurodevelopmental outcomes in all enrolled infants at 5-7, 10-12, and 22-24 months
      corrected age and correlate with FDNIRS-DCS measurements of CBF and CMRO2, and related
      quantities with neurodevelopmental outcomes at approximately 5-7, 10-12, and 22-24 months
      corrected age.
    


Study Type

Observational


Primary Outcome

CMRO2


Condition

Hemorrhage

Intervention

ETV/CPC

Study Arms / Comparison Groups

 GM-IVH
Description:  Premature infants who developed germinal matrix-intraventricular hemorrhage. FDNIRS-DCS measures will be performed up to once a day if clinically feasible.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

70

Start Date

April 2015

Completion Date

December 2023

Primary Completion Date

December 2022

Eligibility Criteria

        1. GM-IVH group:

             Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-32 weeks; < 3
             months old corrected-GA (cGA) at first measure or eligible for measurement within 12
             weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-III IVH
             diagnosed by clinical cranial ultrasound or magnetic resonance imaging (MRI).

             Exclusion criteria for GM-IVH group: chromosomal abnormalities known at the time of
             enrollment; known or suspected metabolic disorder or neoplasm; critical congenital
             heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain
             metabolism, other than GMH-IVH; central nervous system (CNS) infection.

          2. PHH group:

             Inclusion criteria for PHH group: born at gestational age (GA) 24-37 weeks < 3 months
             old cGA at first measure or eligible for measurement within 12 weeks after the infant
             reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial ultrasound or MRI.

             Exclusion criteria for PHH group: chromosomal abnormalities known at the time of
             enrollment; known or suspected metabolic disorder or neoplasm; critical congenital
             heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain
             metabolism, other than IVH-PHH; CNS infection. Implanted devices or other devices that
             preclude the use of MRI.

          3. HC group:

             Inclusion criteria for HC group: born at gestational age (GA) 24-32 weeks; < 3 months
             old cGA at first measure or eligible for measurement within 12 weeks after the infant
             reaches 40 weeks age (PMA); Apgar >7 at 5 min.

             Exclusion criteria for HC group: any clinical indication of brain injury or congenital
             brain malformation; chromosomal abnormality known at the time of enrollment; known or
             suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS
             infection.

          4. VC group:

        Inclusion criteria for VC group: < 12 months old cGA at first measure or eligible for
        measurement within 1 year after the infant reaches 40 weeks age (PMA). Symptomatic
        hydrocephalus of any etiology or at high risk of developing hydrocephalus of any etiology,
        except post-hemorrhagic etiology; characterized by abnormal rate of head growth and full
        anterior fontanelle. Ventricular enlargement diagnosed by ultrasonography or MRI; no signs
        of IVH.

        Exclusion criteria for VC group: known or suspected metabolic disorder or neoplasm;
        critical congenital heart disease; CNS infection. Implanted devices or other devices that
        preclude the use of MRI.
      

Gender

All

Ages

0 Months - 12 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Pei-Yi Lin, PhD, , [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02601339

Organization ID

2014P001713

Secondary IDs

1K99HD083512-01

Responsible Party

Principal Investigator

Study Sponsor

Boston Children's Hospital

Collaborators

 Brigham and Women's Hospital

Study Sponsor

Pei-Yi Lin, PhD, Principal Investigator, Boston Children's Hospital


Verification Date

July 2022