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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: t
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Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
ACTIVE_NOT_RECRUITING
Boston
Boston Children's Hospital
RECRUITING
Boston
Brigham and Women's Hospital
ACTIVE_NOT_RECRUITING
Boston
Contact Information
Primary
Pei-Yi Lin, PhD
ivy.lin@childrens.harvard.edu
Time Frame
Start Date: 2015-04
Estimated Completion Date: 2025-12
Participants
Target number of participants: 70
Treatments
GM-IVH
Premature infants who developed germinal matrix-intraventricular hemorrhage. FDNIRS-DCS measures will be performed up to once a day if clinically feasible.
Posthemorrhagic hydrocephalus (PHH)
Premature infants with complications of hydrocephalus secondary to intraventricular hemorrhage and have the potential to receive endoscopic third ventriculostomy (ETV) with choroid plexus cauterization (CPC) and/or ventriculoperitoneal (VP) shunting for clinical treatment.~FDNIRS-DCS measures will be performed up to once a day if clinically feasible. Additional FDNIRS-DCS measures will be performed on the day of hydrocephalus treatment to monitor the treatment response if clinically feasible. These additional measures are limited to up to four times a day.
Healthy Control (HC)
Premature infants without diagnosed brain injuries. FDNIRS-DCS measures will be performed up to once a day if clinically feasible.
Ventriculomegaly Control (VC)
Infants who have symptomatic hydrocephalus of any etiology except post-hemorrhagic etiology and have the potential to receive ETV/CPC and/or VP shunting for clinical treatment.~FDNIRS-DCS measures will be performed up to once a day if clinically feasible. Additional FDNIRS-DCS measures will be performed on the day of hydrocephalus treatment to monitor the treatment response if clinically feasible. These additional measures are limited to up to four times a day.
Authors
Sponsors
Collaborators: Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov