An observational study in Premature Birth, Neurodevelopmental Disorders and Brain Development Abnormality, sponsored by Children's Hospital Los Angeles. Recruiting at 1 site in United States. Open to participants aged Up to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Children's Hospital Los Angeles · Observational
Among 741 studies in Premature Birth with a site in United States — 103 open to participants now, 135 under way, 9 of them phase 3. Premature Birth · United States.
Among the 741 studies in Premature Birth with a site in United States, this one is the 120th largest by planned enrollment of the 209 observational ones, is one of 40 that started in 2018, is one of 209 observational ones, reaches primary completion later than 27 of the 134 other live ones, and was the 475th registered.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →103 of the 741 studies in Premature Birth with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 313 Premature Birth studies recruiting now, 87 (28%) set no upper age limit and 222 (71%) stop at 75 or younger; 239 take children under 18; 105 take healthy volunteers.
This study: Up to 8 Years · all sexes · healthy volunteers too.
The full table on the hub →741 studies; the count open now beside each. This study's row is marked.
First in 1987; this study’s year is marked. 40 started in 2018.
Median enrollment 86 across the 528 interventional studies, 104 across the 209 observational. Of the 542 that completed or were terminated, 145 (27%) have results posted.
74 of 741 have an industry lead sponsor. The 10 most frequent:
Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Children's Hospital Los Angeles has 1 study filed under Premature Birth — fewer than ten, so there is no comparison to draw.
47 of the studies in Premature Birth with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04614714Phase 3University of California, DavisMilk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants | 2027-08-30 |
| NCT03797183University of Colorado, DenverGenesis Electrical Impedance Tomography (EIT): A Preliminary Study | 2026-11 |
| NCT04372953Murdoch Childrens Research InstitutePositive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). | 2026-11-30 |
| NCT01483079Baylor College of MedicinePost-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU) | 2026-12 |
| NCT07060911Neola Medical IncPivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates | 2026-12 |
Among the 741 studies in Premature Birth with a site in United States, from their registry updates:
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.
The last months of pregnancy are particularly important for the development of the child's brain, and the consequences of premature birth on its development can be substantial. Prematurely born children are at higher risk of various cognitive impairments and exhibits more behavioral disorders than full-term born children. Thus early detection and management of at risk children are essential. There is growing evidence of significant volumetric abnormalities in subcortical structures of premature neonates, which may be associated to negative long-term neurodevelopmental outcomes. Understanding these abnormalities could help elucidate the underlying pathophysiology and enable early determination of at-risk patients, both of which would inform the design of novel treatment strategies. However, to date there is still a lack of sensitive, reliable, and accessible algorithms capable of characterizing the influence of prematurity on the anatomy of neonatal brain subcortical structures. In addition, few studies have looked directly at the long-term neurodevelopmental implications of these neonatal subcortical structures abnormalities. Predicting long-term neurodevelopmental outcomes early on - and preferably at neonatal ages - is likely to have a transformative effect on their outcome. Our preliminary data indicate significant morphological differences in the putamen, ventricles, corpus callosum, and thalamus between preterm and term neonates. Investigators propose to develop biomarkers of prematurity by statistically comparing the morphological and diffusion properties of subcortical structures between preterm and term neonates using brain MRI. These results will further be used in a sparse learning framework to predict long-term neurodevelopmental outcomes of prematurity. Hypotheses: By combining subcortical morphological and diffusion properties, we will 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. Aim 1: Build a new toolbox for neonatal subcortical structures analyses that combine 1) a group lasso-based analysis of significant regions of shape changes, 2) a structural correlation network analysis, 3) a neonatal tractography, and 4) tensor-based analysis on tracts. Aim 2: Ascertain biomarkers of prematurity in neonates with different patterns of abnormalities. Aim 3: Assess the predictive potential of imaging and clinical features on neurodevelopmental outcomes among premature children at 9 and 18 months and 6-8 years of age. Impact: 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. The expected findings could improve the ability to predict these outcomes and enable the design of early treatments - before years of pathological brain development and symptoms occur.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: MRI · Diagnostic Test: Neurodevelopmental/Neuropsychological Assessment
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.
Diagnostic Test: MRI · Diagnostic Test: Neurodevelopmental/Neuropsychological Assessment
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.
Diagnostic Test: Neurodevelopmental/Neuropsychological Assessment
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.
Diagnostic Test: Neurodevelopmental/Neuropsychological Assessment
MRI analysis
Standardized Cognitive and Developmental Tests
Changes in Surface Area and Thickness of Subcortical Structures
Measured in Voxel Size (mm)
Time frame: 2018 - 2022
Changes in Diffusion values of white matter Tracts
Measured in mm squared per second
Time frame: 2018 - 2022
Differences in developmental Quotient / Neuropsychological scores
Measured using standardized tests (Bayley-III and NIH toolbox)
Time frame: 2018 - 2022
Plan to share: Undecided
Started Mar 2018 (actual). Primary completion is estimated for Aug 2025, 89 months after the start.
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