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NCT03410810 · ClinicalTrials.gov registry record
Childhood Outcomes of Preterm Brain Abnormalities
A clinical trial of Premature Birth and Neurodevelopmental Disorders, sponsored by Children's Hospital Los Angeles.
- Recruiting
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT03410810 is a study of Premature Birth and Neurodevelopmental Disorders that is actively recruiting participants, run by Children's Hospital Los Angeles. The registered enrollment target is 80 participants, below the 392-participant average among 38 other Premature Birth trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03410810, a study of Premature Birth and Neurodevelopmental Disorders, is actively recruiting participants, sponsored by Children's Hospital Los Angeles.
- RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
Study 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 appli
Conditions Studied
Interventions
- DIAGNOSTIC_TEST MRI
- DIAGNOSTIC_TEST Neurodevelopmental/Neuropsychological Assessment
Study Locations (1)
California
- Children's Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2025-08-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03410810
The ClinicalTrials.gov registry entry for NCT03410810 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 392-participant average among 38 other Premature Birth trials with a reported enrollment target (80% lower). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Premature Birth appearing as the primary indexed condition, and to 2 interventions - of which MRI is the first listed.
NCT03410810 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03410810 about?
NCT03410810 is a clinical study titled "Childhood Outcomes of Preterm Brain Abnormalities". 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 neurodeve...
What is the current status of trial NCT03410810?
This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2018-03-01. Estimated completion is 2025-08-01.
What conditions does trial NCT03410810 study?
This clinical trial studies the following conditions: Premature Birth, Neurodevelopmental Disorders, Brain Lesion, Brain Development Abnormality.
What interventions are being tested in trial NCT03410810?
The interventions under investigation include: MRI (DIAGNOSTIC_TEST), Neurodevelopmental/Neuropsychological Assessment (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03410810?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03410810 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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