- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02008045
MR Imaging of Perinatal Brain Injury
Advanced MR Imaging of Perinatal Brain Injury: Correlation With Neurocognitive Outcome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nancy H Beluk, RT
- Phone Number: 412-692-3217
- Email: beluknh@upmc.edu
Study Contact Backup
- Name: Christine P Johnson
- Phone Number: 412-692-3214
- Email: christine.johnson@chp.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- Children's Hospital of Pittsburgh of UPMC
-
Contact:
- Nancy H Beluk, RT
- Phone Number: 412-692-3217
- Email: beluknh@upmc.edu
-
Contact:
- Christine P Johnson
- Phone Number: 412-692-3214
- Email: christine.johnson@chp.edu
-
Principal Investigator:
- Ashok Panigrahy, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neonates at Risk for Brian Injury
Magnetic Resonance Imaging Neurodevelopmental Testing - 18 Month
|
Brain MRI without Contrast
Validated battery of neurodevelopmental and psychological tests.
|
Term Neonates
Magnetic Resonance Imaging Neurodevelopmental Testing - 18 Month
|
Brain MRI without Contrast
Validated battery of neurodevelopmental and psychological tests.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Developmental Assessment
Time Frame: 18 Months
|
Administration of neurodevelopmental testing and completion of parent questionnaires regarding the child's development.
|
18 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of White Matter Injury in Brain
Time Frame: Baseline
|
MR Scan
|
Baseline
|
Changes in White Matter Injury from Baseline
Time Frame: at 6 Years
|
MR Scan
|
at 6 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashok Panigrahy, MD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19100215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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