Childhood Outcomes of Preterm Brain Abnormalities
Predicting the Early Childhood Outcomes of Preterm Brain Shape Abnormalities
1 other identifier
observational
80
1 country
1
Brief Summary
Prematurely born children are at higher risk of cognitive impairments and behavioral disorders than full-term children. There is growing evidence of significant volumetric and shape abnormalities in subcortical structures of premature neonates, which may be associated to negative long-term neurodevelopmental outcomes. The general objective is to look directly at the long-term neurodevelopmental implications of these neonatal subcortical structures abnormalities. Investigators propose to develop biomarkers of prematurity by comparing the morphological and diffusion properties of subcortical structures between preterm, with and without associated brain injuries, and full-term neonates using brain MRI. By combining subcortical morphological and diffusion properties, investigators hypothesize to be able to: (1) delineate specific correlative relationships between structures regionally and differentially affected by normal maturation and different patterns of white matter injury, and (2) improve the specificity of neuroimaging to predict neurodevelopmental outcomes earlier. The specific aims and general methodology are: 1) Build a new toolbox for neonatal subcortical structures analyses that combine a group lasso-based analysis of significant regions of shape changes, a structural correlation network analysis, a neonatal tractography, and tensor-based analysis on tracts; 2) Ascertain biomarkers of prematurity in neonates with different patterns of abnormalities using correlational and connectivity analysis within and between structures features; 3) Assess the predictive potential of subcortical imaging on neurodevelopmental outcomes by correlating neonatal imaging results with long-term neurodevelopmental scores at 9 and 18 months, and 6-8 years, follow-up. In each of these aims, investigators will use advanced neuroimaging analysis developed by their group and collaborator, including multivariate tensor-based morphometry and multivariate tract-based analysis. This application will provide the first complete subcortical network analysis in both term and preterm neonates. In the first study of its kind for prematurity, investigators will use sparse and multi-task learning to determine which of the biomarkers of prematurity at birth are the best predictors of long-term outcome. Once implemented, these methods will be available to compare subcortical structures for other pathologies in newborns and children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 25, 2018
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedApril 10, 2024
April 1, 2024
7.4 years
January 19, 2018
April 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes in Surface Area and Thickness of Subcortical Structures
Measured in Voxel Size (mm)
2018 - 2022
Changes in Diffusion values of white matter Tracts
Measured in mm squared per second
2018 - 2022
Differences in developmental Quotient / Neuropsychological scores
Measured using standardized tests (Bayley-III and NIH toolbox)
2018 - 2022
Study Arms (4)
Infant Control Group
The control arm (term born Infants) will receive an MRI at neonatal age and neurodevelopmental follow-up assessments, investigators will then compare significant morphological and diffusion properties within the brain to those of a Preterm brain.
Infant Preterm Group
The experimental group will consist of preterm infants, who will receive an MRI at neonatal age and neurodevelopmental assessments. This groups scans will then be compared to those of the control arm. Significant biomarkers will then be identified.
Childhood Control Group
The experimental group will consist of preterm born children aged 6-8 years, who received an MRI at neonatal age and will be called back for a neuropsychological assessment. This groups scans will then be compared to those of the children control arm. Significant biomarkers will then be identified.
Childhood Preterm Group
The experimental group will consist of term born children aged 6-8 years, who received an MRI at neonatal age and will be called back for a neuropsychological assessment. This groups scans will then be compared to those of the children preterm group. Significant biomarkers will then be identified.
Interventions
Standardized Cognitive and Developmental Tests
Eligibility Criteria
Our MRI data will consist of two separate neonatal cohorts. Cohort 1 is an existing dataset of neonates scanned in Pittsburgh as part of a separate completed grant. This cohort was scanned at neonatal equivalent age and will be brought back for childhood neurodevelopmental outcomes at 6-8 years of age. Cohort 2 will be a new prospectively recruited cohort that will be scanned in Los Angeles as part of this proposal and will be brought back for infant neurodevelopmental outcome at 9 and 18 months.
You may qualify if:
- Preterm birth (Gestational Age 21-36 weeks)
- English or Spanish speaking families
- PVL and Grade I and II IVH will be considered
You may not qualify if:
- Shunt
- Intubation, Cpap, Nasal Ventilation
- Chromosomal/Genetic abnormalities
- Mitochondrial/Metabolic Diseases
- Treatment for extracorporeal membrane oxygenation (ECMO)
- Grade III and IV IVH (optional)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Los Angeleslead
- University of Pittsburghcollaborator
- Arizona State Universitycollaborator
Study Sites (1)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Related Publications (2)
Paquette N, Shi J, Wang Y, Lao Y, Ceschin R, Nelson MD, Panigrahy A, Lepore N. Ventricular shape and relative position abnormalities in preterm neonates. Neuroimage Clin. 2017 May 28;15:483-493. doi: 10.1016/j.nicl.2017.05.025. eCollection 2017.
PMID: 28649491BACKGROUNDLao Y, Wang Y, Shi J, Ceschin R, Nelson MD, Panigrahy A, Lepore N. Thalamic alterations in preterm neonates and their relation to ventral striatum disturbances revealed by a combined shape and pose analysis. Brain Struct Funct. 2016 Jan;221(1):487-506. doi: 10.1007/s00429-014-0921-7. Epub 2014 Nov 1.
PMID: 25366970BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Research Radiology
Study Record Dates
First Submitted
January 19, 2018
First Posted
January 25, 2018
Study Start
March 1, 2018
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
April 10, 2024
Record last verified: 2024-04