Perinatal White Matter Brain Injury Clinical Trial
Official title:
Advanced MR Imaging of Perinatal Brain Injury: Correlation With Neurocognitive Outcome
NCT number | NCT02008045 |
Other study ID # | STUDY19100215 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2009 |
Est. completion date | December 2026 |
The purpose of this study is to collect and compare information from cranial ultrasounds, magnetic resonance imaging scans, neurological exam and neuropsychological assessments of children. The investigators hope that the information collected in this study will help with early screening, diagnosis and treatment of brain injury in newborns as well as identify a connection between MR imaging (MRI-magnetic resonance imaging, MRS-magnetic resonance spectroscopy) and neurodevelopmental outcome.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 7 Years |
Eligibility | Inclusion Criteria: - Preterm babies and neonates with congenital heart disease - Term Neonates Exclusion Criteria: - Severe congenital brain malformation - Significant chromosomal abnormality / syndrome which could confound the neurodevelopmental follow up data - Preterm birth and congenital heart disease - Focal neurological abnormality - Chronic seizures - Severe congenital brain malformation - Significant chromosomal abnormality/ syndrome which could confound the neurodevelopmental follow up data - Major pregnancy complication (diabetes, eclampsia) - Sepsis - ECMO - Significant birth trauma and/or hypoxic ischemic injury |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Developmental Assessment | Administration of neurodevelopmental testing and completion of parent questionnaires regarding the child's development. | 18 Months | |
Secondary | Assessment of White Matter Injury in Brain | MR Scan | Baseline | |
Secondary | Changes in White Matter Injury from Baseline | MR Scan | at 6 Years |