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NCT02601339 · ClinicalTrials.gov registry record
NIRS Monitoring in Premature Infants
A clinical trial of Hemorrhage and Hydrocephalus, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 70
- Enrollment target
- 3
- Study locations
NCT02601339: Recruiting study of Hemorrhage and Hydrocephalus, sponsored by Boston Children's Hospital.
NCT02601339 is a study of Hemorrhage and Hydrocephalus that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 70 participants, below the 263-participant average among 20 other Hemorrhage trials with a reported enrollment target (73% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601339, a study of Hemorrhage and Hydrocephalus, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 70 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
The primary outcomes are FDNIRS-DCS-measured CMRO2 trajectory.
Conditions Studied
Interventions
- PROCEDURE ETV/CPC
Study Locations (3)
Massachusetts
- Boston Children's Hospital - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2015-04 |
| Est. Completion | 2026-12 |
What NCT02601339 shows while recruiting
NCT02601339 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 263-participant average among 20 other Hemorrhage trials with a reported enrollment target (73% lower).
The record links to 4 conditions, with Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which ETV/CPC is the first listed.
NCT02601339 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02601339 about?
NCT02601339 is a clinical study titled "NIRS Monitoring in Premature Infants". 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/...
What is the current status of trial NCT02601339?
This trial is currently recruiting. The enrollment target is 70 participants. The study started on 2015-04. Estimated completion is 2026-12.
What conditions does trial NCT02601339 study?
This clinical trial studies the following conditions: Hemorrhage, Hydrocephalus, Premature Infants, Newborn.
What interventions are being tested in trial NCT02601339?
The interventions under investigation include: ETV/CPC (PROCEDURE).
Who is sponsoring clinical trial NCT02601339?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02601339 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemorrhage
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02601339's enrollment target sits among peer trials
70 13th of 20 higher than 8 of 20 other Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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