← Back to Clinical Trials
Recruiting NCT02601339

NIRS Monitoring in Premature Infants

Trial Parameters

Condition Hemorrhage
Sponsor Boston Children's Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 0 Months
Max Age 12 Months
Start Date 2015-04
Completion 2026-12
Interventions
ETV/CPC

Brief 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 Criteria

1. GM-IVH group: Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-32 weeks; \< 3 months old corrected-GA (cGA) at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-III IVH diagnosed by clinical cranial ultrasound or magnetic resonance imaging (MRI). Exclusion criteria for GM-IVH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than GMH-IVH; central nervous system (CNS) infection. 2. PHH group: Inclusion criteria for PHH group: born at gestational age (GA) 24-37 weeks \< 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial ultrasound or MRI. Exclusion criteria for PHH group: chromosomal abnormalities known

Related Trials