RECRUITING

Childhood Outcomes of Preterm Brain Abnormalities

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Predicting the Early Childhood Outcomes of Preterm Brain Shape Abnormalities

Quick Facts

Study Start:2018-03-01
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03410810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Preterm birth (Gestational Age 21-36 weeks)
  2. * English or Spanish speaking families
  3. * PVL and Grade I and II IVH will be considered
  1. * Shunt
  2. * Intubation, Cpap, Nasal Ventilation
  3. * Chromosomal/Genetic abnormalities
  4. * Mitochondrial/Metabolic Diseases
  5. * Treatment for extracorporeal membrane oxygenation (ECMO)
  6. * Grade III and IV IVH (optional)

Contacts and Locations

Study Contact

Natasha Lepore, Phd
CONTACT
(323) 361-5088
nlepore@chla.usc.edu
Natacha Paquette, Phd
CONTACT
(323) 361-8726
npaquette@chla.usc.edu

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-01
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2018-03-01
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

  • Prematurity
  • Neuroimaging

Additional Relevant MeSH Terms

  • Premature Birth
  • Neurodevelopmental Disorders
  • Brain Development Abnormality
  • Brain Lesion