Cell proliferation in human ganglionic eminence and suppression after prematurity-associated haemorrhage.
Marc R Del Bigio
https://pubmed.ncbi.nlm.nih.gov/21478186/Actively Recruiting
Led by Boston Children's Hospital · Updated on 2026-03-18
70
Participants Needed
3
Research Sites
N/A
Total Duration
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
NIRS Monitoring in Premature Infants
P
Pei-Yi Lin, PhD
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Boston Children's Hospital
Lead Sponsor
Brigham and Women's Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/20935909/Boston Children's Hospital
Lead Sponsor
Brigham and Women's Hospital
Collaborating Sponsor