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OpenTrials
Completed

NCT Number: NCT02008045

MR Imaging of Perinatal Brain Injury

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.

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Key information

Age range

1 day–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Device

Brain MRI without Contrast

Neurodevelopmental Testing

Behavioral

Validated battery of neurodevelopmental and psychological tests.

Primary outcomes

  1. Developmental Assessment

    Time frame: 18 Months

    Administration of neurodevelopmental testing and completion of parent questionnaires regarding the child's development.

Secondary outcomes

  1. Assessment of White Matter Injury in Brain

    Time frame: Baseline

    MR Scan

  2. Changes in White Matter Injury from Baseline

    Time frame: at 6 Years

    MR Scan

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2013
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.