MR Imaging of Perinatal Brain Injury

November 9, 2023 updated by: Ashok Panigrahy, University of Pittsburgh

Advanced MR Imaging of Perinatal Brain Injury: Correlation With Neurocognitive Outcome

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.

Study Overview

Detailed Description

In the last two decades, major advances have been made in the clinical care of premature and term infants, including in the management of sepsis and respiratory compromise that can contribute to neurological disabilities in survivors. The incidence of classic cystic periventricular leukomalacia (PVL) has declined and a more diffuse and non-cystic pattern of cerebral white matter injury is more predominant. Although multiple pathologies occur in premature infants, the principal variety accounting for the predominance of neurodevelopmental disability is PVL. This disability in very low birth weight infants (VLBW) (< 1500 grams) includes cognitive/behavioral deficits in 25-50% and cerebral palsy in 5-10%. Neuroimaging studies of VLBW survivors suggest that the cerebral palsy is related to the focal necrotic lesions of PVL, whereas the cognitive/behavioral deficits correlate with more diffuse cerebral white matter injury. PVL is defined as damaged immature cerebral white matter with periventricular focal necrosis ("focal" component) in association with diffuse reactive gliosis and microglial activation in the surrounding white matter ("diffuse" component). Of note, PVL occurs in the late preterm infant and the term infant, particularly in cases of congenital heart disease. The pathogenesis of perinatal white matter injury is currently thought to be related to a complex interaction between maternal/fetal infection, cytokines and hypoxia-ischemia which results in both the generation of reactive oxygen specific agents (oxidative stress), apoptotic oligodendrocyte cell death, and axonal injury. In long-term survivors with PVL, neuroimaging studies often demonstrate reduced cerebral white matter volume, impaired myelination, ventriculomegaly and reduced volume in the cerebral cortex, thalamus/basal ganglia and cerebellum. In many of these long-term studies, the preterm children studies had normal cranial ultrasound. Cranial ultrasound, however, is not adequate for assessing non-cystic focal or diffuse white matter injury. To date, there are no longitudinal MR studies of preterm or congenital heart disease infants which correlate advanced neonatal MR imaging techniques with long-term neurodevelopmental outcome or advanced MR techniques performed in the childhood period.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashok Panigrahy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 7 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants will be enrolled between birth and 7 years of age.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ashok Panigrahy, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimated)

December 11, 2013

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

De-identified data will be shared once all study subjects have completed participation and data analysis has been completed.

IPD Sharing Access Criteria

De-identified data will be shared via secure website with access granted by PI research team.

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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