NIRS Monitoring in Premature Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorBoston Children's Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The subject population will include premature and full-term neonates that fit criteria for one of the GM-IVH, PHH, HC, or VC groups.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ETV/CPC
Procedure/Surgeryendoscopic third ventriculostomy (ETV) combined with choroid plexus cauterization (CPC) is a surgical procedure to treat infant hydrocephalus
Treatment groups
70 Participants
are divided into 4 treatment groupsGroup A: GM-IVH0 interventions
Group B: Posthemorrhagic hydrocephalus (PHH)1 intervention
Group C: Healthy Control (HC)0 interventions
Group D: Ventriculomegaly Control (VC)1 intervention
Trial outcomes
Primary outcomes
1
CMRO2
The primary outcomes are FDNIRS-DCS-measured CMRO2 trajectory.
Time frame
0-2 years oldSponsors and contacts
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Boston Children's Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov