Perinatal White Matter Brain InjuryNCT02008045
MR Imaging of Perinatal Brain Injury
An observational study of Perinatal White Matter Brain Injury, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 7 years
- Conditions the study is for
- Perinatal White Matter Brain Injury
- What is being tested?
- Magnetic Resonance Imaging and Neurodevelopmental Testing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 557 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2009to 2 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be enrolled between birth and 7 years of age.
Who may be able to join
- Preterm babies and neonates with congenital heart disease
- Term Neonates
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Official title: 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.
Read the 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.
- Conditions
- Perinatal White Matter Brain Injury
- Being tested
- Magnetic Resonance Imaging, Neurodevelopmental Testing
- Keywords
- MRI, Imaging, Neurocognitive, White matter injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Brain MRI without Contrast
Neurodevelopmental TestingBehavioural
Validated battery of neurodevelopmental and psychological tests.
| Study group | Role | What they receive |
|---|---|---|
| Neonates at Risk for Brian Injury | Magnetic Resonance Imaging Neurodevelopmental Testing - 18 Month Receives: Device: Magnetic Resonance Imaging; Behavioral: Neurodevelopmental Testing | |
| Term Neonates | Magnetic Resonance Imaging Neurodevelopmental Testing - 18 Month Receives: Device: Magnetic Resonance Imaging; Behavioral: Neurodevelopmental Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Assessment
Administration of neurodevelopmental testing and completion of parent questionnaires regarding the child's development.
Measured: 18 Months
Secondary outcomes (2)
Assessment of White Matter Injury in Brain
MR Scan
Measured: Baseline
Changes in White Matter Injury from Baseline
MR Scan
Measured: at 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start1 Jul 2009
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal White Matter Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Ceschin, University of Pittsburgh
- Investigators
- Ashok Panigrahy, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008045
- Sponsor's protocol ID
- STUDY19100215
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2013
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MR Imaging of Perinatal Brain Injury: Correlation With Neurocognitive Outcome
- ClinicalTrials.gov ID
- NCT02008045
- Acronym / sponsor ID
- STUDY19100215
- Conditions
- Perinatal White Matter Brain Injury
- Keywords
- MRI, Imaging, Neurocognitive, White matter injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates at Risk for Brian Injury | – | Device: Magnetic Resonance Imaging, Behavioral: Neurodevelopmental TestingMagnetic Resonance Imaging Neurodevelopmental Testing - 18 Month |
| Term Neonates | – | Device: Magnetic Resonance Imaging, Behavioral: Neurodevelopmental TestingMagnetic Resonance Imaging Neurodevelopmental Testing - 18 Month |
Who may qualify
- Ages
- 1 day to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be enrolled between birth and 7 years of age.
Key inclusion criteria (2 listed)
- Preterm babies and neonates with congenital heart disease
- Term Neonates
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingBrain MRI without Contrast | Device | Neonates at Risk for Brian Injury, Term Neonates |
| Neurodevelopmental TestingValidated battery of neurodevelopmental and psychological tests. | Behavioural | Neonates at Risk for Brian Injury, Term Neonates |
Primary outcome
Developmental Assessment
Time frame: 18 Months
Administration of neurodevelopmental testing and completion of parent questionnaires regarding the child's development.
2 secondary outcomes
Assessment of White Matter Injury in Brain
Time frame: Baseline
Changes in White Matter Injury from Baseline
Time frame: at 6 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Panigrahy, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal White Matter Brain Injury, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Assessment (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.