MR Imaging of Perinatal Brain Injury
Advanced MR Imaging of Perinatal Brain Injury: Correlation With Neurocognitive Outcome
1 other identifier
observational
557
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 15, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2025
CompletedJanuary 13, 2026
January 1, 2026
15.9 years
November 15, 2013
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Developmental Assessment
Administration of neurodevelopmental testing and completion of parent questionnaires regarding the child's development.
18 Months
Secondary Outcomes (2)
Assessment of White Matter Injury in Brain
Baseline
Changes in White Matter Injury from Baseline
at 6 Years
Study Arms (2)
Neonates at Risk for Brian Injury
Magnetic Resonance Imaging Neurodevelopmental Testing - 18 Month
Term Neonates
Magnetic Resonance Imaging Neurodevelopmental Testing - 18 Month
Interventions
Brain MRI without Contrast
Validated battery of neurodevelopmental and psychological tests.
Eligibility Criteria
Participants will be enrolled between birth and 7 years of age.
You may qualify if:
- Preterm babies and neonates with congenital heart disease
- Term Neonates
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashok Panigrahy, MD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 15, 2013
First Posted
December 11, 2013
Study Start
July 1, 2009
Primary Completion
June 2, 2025
Study Completion
June 2, 2025
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- De-identified data will be shared once all study subjects have completed participation and data analysis has been completed.
- Access Criteria
- De-identified data will be shared via secure website with access granted by PI research team.
Materials generated under the project will be disseminated in accordance with the University of Pittsburgh and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.