MR Imaging of Perinatal Brain Injury

Perinatal White Matter Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02008045
• Other study ID #: STUDY19100215
• Status: Recruiting
• Start date: April 2009
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Nancy H Beluk, RT
• Phone: 412-692-3217
• Email: beluknh[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Brain Injuries
• Perinatal White Matter Brain Injury
• Wounds and Injuries

Intervention

Device:
• Magnetic Resonance Imaging
Brain MRI without Contrast

Behavioral:
• Neurodevelopmental Testing
Validated battery of neurodevelopmental and psychological tests.

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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