[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100255235":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":38,"responsibleParty":68,"collaborators":71,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":10,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,12,17,20],{"label":9,"type":10,"description":11,"interventionNames":10},"GM-IVH",null,"Premature infants who developed germinal matrix-intraventricular hemorrhage. FDNIRS-DCS measures will be performed up to once a day if clinically feasible.",{"label":13,"type":10,"description":14,"interventionNames":15},"Posthemorrhagic hydrocephalus (PHH)","Premature infants with complications of hydrocephalus secondary to intraventricular hemorrhage and have the potential to receive endoscopic third ventriculostomy (ETV) with choroid plexus cauterization (CPC) and\u002For ventriculoperitoneal (VP) shunting for clinical treatment.\n\nFDNIRS-DCS measures will be performed up to once a day if clinically feasible. Additional FDNIRS-DCS measures will be performed on the day of hydrocephalus treatment to monitor the treatment response if clinically feasible. These additional measures are limited to up to four times a day.",[16],"Procedure: ETV\u002FCPC",{"label":18,"type":10,"description":19,"interventionNames":10},"Healthy Control (HC)","Premature infants without diagnosed brain injuries. FDNIRS-DCS measures will be performed up to once a day if clinically feasible.",{"label":21,"type":10,"description":22,"interventionNames":23},"Ventriculomegaly Control (VC)","Infants who have symptomatic hydrocephalus of any etiology except post-hemorrhagic etiology and have the potential to receive ETV\u002FCPC and\u002For VP shunting for clinical treatment.\n\nFDNIRS-DCS measures will be performed up to once a day if clinically feasible. Additional FDNIRS-DCS measures will be performed on the day of hydrocephalus treatment to monitor the treatment response if clinically feasible. These additional measures are limited to up to four times a day.",[16],[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"PROCEDURE","ETV\u002FCPC","endoscopic third ventriculostomy (ETV) combined with choroid plexus cauterization (CPC) is a surgical procedure to treat infant hydrocephalus",[13,21],[31],{"name":32,"affiliation":5,"role":33},"Pei-Yi Lin, PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":10,"phoneExt":10,"email":37},"CONTACT","ivy.lin@childrens.harvard.edu",[39,56,62],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-71.05977,42.35843,{"lat":50,"lon":49},[53,55],{"name":32,"role":36,"phone":10,"phoneExt":10,"email":54},"Ivy.Lin@childrens.harvard.edu",{"name":32,"role":33,"phone":10,"phoneExt":10,"email":10},{"facility":57,"status":58,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":61,"contacts":10},"Brigham and Women's Hospital","ACTIVE_NOT_RECRUITING",{"type":47,"coordinates":60},[49,50],{"lat":50,"lon":49},{"facility":63,"status":58,"city":41,"state":42,"zip":64,"country":44,"countryCode":45,"cosmosGeoPoint":65,"geoPoint":67,"contacts":10},"Beth Israel Deaconess Medical Center","02215",{"type":47,"coordinates":66},[49,50],{"lat":50,"lon":49},{"type":33,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Pei-Yi Lin","Assistant Professor",[72,73,74],{"name":57,"class":6},{"name":63,"class":6},{"name":75,"class":76},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100255235","nirs-monitoring-in-premature-infants-100255235",false,"NCT02601339","NIRS Monitoring in Premature Infants","Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus","1. GM-IVH group:\n\n   Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-32 weeks; \\\u003C 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).\n\n   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.\n2. PHH group:\n\n   Inclusion criteria for PHH group: born at gestational age (GA) 24-37 weeks \\\u003C 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.\n\n   Exclusion criteria for PHH 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 IVH-PHH; CNS infection. Implanted devices or other devices that preclude the use of MRI.\n3. HC group:\n\n   Inclusion criteria for HC group: born at gestational age (GA) 24-32 weeks; \\\u003C 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA); Apgar \\>7 at 5 min.\n\n   Exclusion criteria for HC group: any clinical indication of brain injury or congenital brain malformation; chromosomal abnormality known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection.\n4. VC group:\n\nInclusion criteria for VC group: \\\u003C 12 months old cGA at first measure or eligible for measurement within 1 year after the infant reaches 40 weeks age (PMA). Symptomatic hydrocephalus of any etiology or at high risk of developing hydrocephalus of any etiology, except post-hemorrhagic etiology; characterized by abnormal rate of head growth and full anterior fontanelle. Ventricular enlargement diagnosed by ultrasonography or MRI; no signs of IVH.\n\nExclusion criteria for VC group: known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. Implanted devices or other devices that preclude the use of MRI.",true,"ALL","0 Months","12 Months",{"count":89,"type":90},70,"ESTIMATED","OBSERVATIONAL","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\u002For 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.\n\nThis 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.",[94,95,96,97],"Hemorrhage","Premature Infants","Newborn","Hydrocephalus",[99],"spectroscopy, Near-Infrared","2026-03-16",{"date":102,"type":103},"2026-03-18","ACTUAL",{"date":105,"type":103},"2015-04",{"date":107,"type":90},"2026-12",{"name":5,"class":6},3]