Recruiting

Observational Study

Sponsor:

Children's Hospital Los Angeles

Code:

NCT03410810

Conditions

Premature Birth

Neurodevelopmental Disorders

Brain Development Abnormality

Brain Lesion

Eligibility Criteria

Sex: All

Age: 0 - 8

Healthy Volunteers: Accepted

Interventions

MRI

Neurodevelopmental/Neuropsychological Assessment

Study Details

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.

Conditions

Premature Birth

Neurodevelopmental Disorders

Brain Development Abnormality

Brain Lesion

Study ID

NCT03410810

Start date

Mar 1, 2018

Status verified date

Apr, 2024

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 8

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Preterm birth (Gestational Age 21-36 weeks)
  • English or Spanish speaking families
  • PVL and Grade I and II IVH will be considered

Exclusion Criteria:

  • Shunt
  • Intubation, Cpap, Nasal Ventilation
  • Chromosomal/Genetic abnormalities
  • Mitochondrial/Metabolic Diseases
  • Treatment for extracorporeal membrane oxygenation (ECMO)
  • Grade III and IV IVH (optional)

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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

MRI

MRI analysis

Neurodevelopmental/Neuropsychological Assessment

Standardized Cognitive and Developmental Tests

Primary outcome measure

  • Changes in Surface Area and Thickness of Subcortical Structures [ Time Frame: 2018 - 2022 ]
  • Changes in Diffusion values of white matter Tracts [ Time Frame: 2018 - 2022 ]
  • Differences in developmental Quotient / Neuropsychological scores [ Time Frame: 2018 - 2022 ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Apr 10, 2024

Last verified

Apr, 2024

Keywords

  • Prematurity
  • Neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2024-04-10.