Actively Recruiting
NIRS Monitoring in Premature Infants
Led by Boston Children's Hospital · Updated on 2026-03-18
70
Participants Needed
3
Research Sites
608 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
B
Brigham and Women's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NIRS Monitoring in Premature Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born at gestational age 24-32 weeks for GM-IVH and healthy control groups
- Born at gestational age 24-37 weeks for PHH group
- Less than 3 months corrected gestational age at first measurement or eligible within 12 weeks after reaching 40 weeks post-menstrual age for GM-IVH, PHH, and healthy control groups
- Diagnosed with Grade I-III intraventricular hemorrhage for GM-IVH group
- Diagnosed with post-hemorrhagic hydrocephalus for PHH group
- Apgar score greater than 7 at 5 minutes for healthy controls
- Less than 12 months corrected gestational age at first measurement or eligible within 1 year after reaching 40 weeks post-menstrual age for ventricular enlargement group
- Symptomatic hydrocephalus of any cause other than post-hemorrhagic etiology for ventricular enlargement group
- Ventricular enlargement diagnosed by ultrasonography or MRI for ventricular enlargement group
You will not qualify if you...
- Known chromosomal abnormalities at time of enrollment
- Known or suspected metabolic disorder or neoplasm
- Critical congenital heart disease
- Congenital hydrocephalus for GM-IVH and PHH groups
- Brain lesions affecting cerebral metabolism other than GM-IVH or PHH
- Central nervous system infection
- Implanted devices or other devices that prevent use of MRI for PHH and ventricular enlargement groups
- Clinical indication of brain injury or congenital brain malformation for healthy control group
- Signs of intraventricular hemorrhage for ventricular enlargement group
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Active, Not Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
Research Team
P
Pei-Yi Lin, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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