Scattering and Imaging with Diffusing Temporal Field Correlations.
DA Boas, LE Campbell, AG Yodh
https://pubmed.ncbi.nlm.nih.gov/10060408Actively Recruiting
Age: 0Months - 12Months
All Genders
Healthy Volunteers
ID02601339
Bedside Monitoring of Brain Metabolism in Premature Infants with Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus
Led by Boston Children's Hospital · Updated on 2026-03-18
70
Participants Needed
3
Research Sites
N/A
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
Researchers are studying premature newborns with brain bleeding called germinal matrix-intraventricular hemorrhage (GM-IVH) and related swelling of the brain called post-hemorrhagic hydrocephalus (PHH). They are using a special technology called frequency domain near-infrared spectroscopy combined with diffuse correlation spectroscopy (FDNIRS-DCS) to monitor blood flow and oxygen use in the brain. The study compares these infants to others with hydrocephalus from other causes and to healthy infants, aiming to find better ways to measure brain metabolism and predict outcomes. The study observes four groups of infants: those with GM-IVH, those with PHH who may receive surgical treatments like endoscopic third ventriculostomy (ETV) with choroid plexus cauterization (CPC) or shunting, healthy premature infants, and infants with other types of hydrocephalus. FDNIRS-DCS measurements are taken up to once daily when possible, with extra measurements on treatment days for those receiving surgery, up to four times a day to monitor response. Parents and caregivers will have their infants monitored at the bedside with the non-invasive FDNIRS-DCS technology. The study collects data on brain blood flow and oxygen metabolism, and follows neurodevelopmental outcomes at 5-7, 10-12, and 22-24 months corrected age. This helps researchers understand how brain metabolism relates to brain injury severity and treatment response. The total study duration for participants is up to about one year of age with follow-up assessments extending beyond that.
CONDITIONS
Brief Title
NIRS Monitoring in Premature Infants
Who Can Participate
Age: 0Months - 12Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Born at gestational age 24-32 weeks (GM-IVH and healthy control groups) or 24-37 weeks (PHH group)
- Less than 3 months corrected gestational age at first measurement or eligible within 12 weeks after 40 weeks post-menstrual age (GM-IVH, PHH, and healthy controls)
- Diagnosed with Grade I-III IVH by ultrasound or MRI (GM-IVH group)
- Diagnosed with post-hemorrhagic hydrocephalus by ultrasound or MRI (PHH group)
- Healthy premature infants without diagnosed brain injuries with Apgar score greater than 7 at 5 minutes (healthy control group)
- Less than 12 months corrected gestational age at first measurement or eligible within 1 year after 40 weeks post-menstrual age (ventriculomegaly control group)
- Symptomatic hydrocephalus of any cause except post-hemorrhagic, characterized by abnormal head growth and ventricular enlargement without signs of IVH (ventriculomegaly control group)
You will not qualify if you...
- Known chromosomal abnormalities at 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 IVH-PHH
- Central nervous system infection
- Implanted devices that prevent MRI use (PHH and ventriculomegaly groups)
- Any clinical indication of brain injury or congenital brain malformation (healthy controls)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 12 weeks after 40 weeks post-menstrual age or up to 12 months corrected gestational age depending on group
Participants undergo FDNIRS-DCS measurements of cerebral oxygen metabolism and blood flow to assess brain metabolism and response to hydrocephalus treatment if applicable.
Up to once daily measurements if clinically feasible; On hydrocephalus treatment days, up to four measurements may be performed
Long-term Monitoring
Duration - Up to 24 months corrected age
Participants have neurodevelopmental assessments at 5-7, 10-12, and 22-24 months corrected age to evaluate developmental outcomes correlated with earlier cerebral metabolism measurements.
3 visits for neurodevelopmental assessments
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
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Research Team
P
Pei-Yi Lin, PhD
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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Marc R Del Bigio
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https://pubmed.ncbi.nlm.nih.gov/23524854