NIRS Monitoring in Premature Infants with Hemorrhage and Hydrocephalus

This study is observing premature infants who have experienced bleeding in the brain (germinal matrix-intraventricular hemorrhage or GM-IVH) and/or developed fluid buildup in the brain (post-hemorrhagic hydrocephalus or PHH). Researchers are using a special technology called FDNIRS-DCS to measure blood flow and how the brain uses oxygen (CMRO2) at the bedside. They want to see if these measurements can better show how severe the conditions are and how well treatments for hydrocephalus, like ETV/CPC surgery, are working. The study includes infants born between 24-32 weeks gestation, up to 12 months old, who have been diagnosed with GM-IVH. The goal is to compare these infants to healthy babies and those with hydrocephalus from other causes.

Study design
This is an observational study, meaning researchers are watching and collecting information without giving any new treatments. It plans to include 70 participants.
What's involved
Participants will have their cerebral oxygen metabolism (CMRO2) measured. The study will follow participants for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to measure CMRO2.

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NCT02601339

NIRS Monitoring in Premature Infants

Recruiting
Not specifiedAges 0–12Observational
Boston Children's Hospital
~70 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:ETV/CPC

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CMRO2
Measured over 0-2 years old
Hemorrhage
Premature Infants
Newborn
Hydrocephalus
3 sites across 1 states
Massachusetts3
  • Pei-Yi Lin, PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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  • CMRO20-2 years old

    The primary outcomes are FDNIRS-DCS-measured CMRO2 trajectory.