Examining brain development in prematurely born children
Predicting the Early Childhood Outcomes of Preterm Brain Shape Abnormalities
Children's Hospital Los Angeles · NCT03410810
This study looks at how being born early affects brain development in children to see if certain brain differences can help predict learning and behavior challenges later on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | N/A to 8 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03410810 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the long-term neurodevelopmental outcomes of children born prematurely by analyzing the morphological and diffusion properties of their subcortical brain structures using MRI. The study aims to identify specific abnormalities in these structures that may correlate with cognitive impairments and behavioral disorders. By comparing preterm neonates with and without brain injuries to full-term neonates, researchers hope to develop biomarkers that can predict neurodevelopmental risks early in life. This could lead to improved early detection and management strategies for at-risk children.
Who should consider this trial
Good fit: Ideal candidates for this study are families with children who were born preterm (gestational age 21-36 weeks) and speak English or Spanish.
Not a fit: Patients who have undergone shunt procedures, require intubation or ventilation, or have chromosomal/genetic abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification of at-risk children and inform novel treatment strategies to improve their neurodevelopmental outcomes.
How similar studies have performed: While there is growing evidence regarding brain abnormalities in preterm infants, this study aims to develop novel biomarkers, making it a potentially unique approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Los Angeles, California
- Children's Hospital Los Angeles — Los Angeles, California, United States (RECRUITING)
Study contacts
- Study coordinator: Natasha Lepore, Phd
- Email: nlepore@chla.usc.edu
- Phone: (323) 361-5088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Birth, Neurodevelopmental Disorders, Brain Development Abnormality, Brain Lesion, Prematurity, Neuroimaging