Project overview:
The overarching goal of the Pediatric MRI Study is to foster a better understanding of normal brain maturation as a basis for understanding atypical brain development associated with a variety of disorders and diseases.
This seven year study uses magnetic resonance technologies to further our knowledge of brain maturation in healthy, typically-developing infants, children, and adolescents and to correlate brain development with cognitive and behavioral development. The information obtained in this study will provide essential data for understanding the course of normal brain development as a basis for understanding atypical brain development associated with a variety of developmental, neurological, and neuropsychiatric disorders affecting children and adults.
This study aims to enroll over 500 children, ranging from infancy to young adulthood. The goal is to study each participant at least three times over the course of the project at one of six Pediatric Centers across the United States. Brain MR and clinical/behavioral data are being compiled and analyzed at a Data Coordinating Center and Clinical Coordinating Center. Additionally, MR spectroscopy and DTI data are being analyzed.The study is organized around two objectives corresponding to two age ranges at the time of enrollment, each with its own protocols.
Objective 1 enrolled children ages 4 years, 6 months through 18 years (total N = 433). This sample was recruited across the six Pediatric Study Centers using community based sampling to reflect the demographics of the United States in terms of income, race, and ethnicity. The subjects are studied with both imaging and clinical/behavioral measures at two year intervals for three time points. Recruitment is complete, but data collection is still ongoing.
Objective 2 is enrolling newborns, infants, toddlers, and preschoolers from birth through 4 years, 5 months, who are studied three or more times at two Pediatric Study Centers at intervals ranging from three months for the youngest subjects to one year as the children approach the Objective 1 age range. Both imaging and clinical/behavioral measures are collected at each time point. Participant recruitment uses community based sampling that includes hospital venues (e.g., maternity wards and nurseries, satellite physician offices, and well-child clinics), community organizations (e.g., day-care centers, schools, and churches), and siblings of children participating in other research at the Pediatric Study Centers. Recruitment is ongoing. The targeted minimum sample size is 106.
Anatomic MRI constitutes the study's core imaging modality. Scans are attempted for all subjects and data points. While the success rate is high, some data is missing due to artifacts associated with child movement or poor compliance associated with unsedated scanning, missed visits due to dental braces, and attrition over the course of the study.
Ancillary studies include DTI and MRS, both single voxel (MRS) and MRS imaging (MRSI). These data are collected at a subset of the Study Centers, as shown below:
Pediatric Study Center
Objective 1
Objective 2
Single Voxel MRS(MRS)
/MRS imaging (MRSI)Standard DTI
Expanded DTI
Children's Hospital Boston Cincinnati Children's Hospital Medical Center The University of Texas Health Science Center at Houston University of California, Los Angeles The Children's Hospital of Philadelphia Washington University in St. Louis List of project investigators (Word Document)
Clinical/behavioral measures include physical neurological examinations, behavioral ratings, neuropsychological testing, structured psychiatric interviews, and hormonal measures from urine and saliva samples.
Data release plan: The data will be released in stages. The first data release will include MR images and clinical/behavioral data from the first assessments, Visit 1, for Objective 1. Subsequent data releases will include data from follow-up visits, processed anatomical MRI, DTI, and spectroscopy data. Each data release will be identified by a version number.
