Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT03345069
The Early Prediction Study is a longitudinal population-based cohort study for very preterm infants ≤32 weeks gestational age. Preterm infants recruited from three greater Cincinnati and two Dayton area neonatal intensive care units (NICUs) will undergo advanced MRIs at 41 weeks postmenstrual age and neurodevelopmental testing at the corrected ages of two and three years correct age. The goal of the Early Prediction Study is to accurately predict motor, cognitive, and behavioral deficits in individual very preterm infants using neuroimaging technologies and established epidemiologic approaches.
This study is active but is not currently recruiting participants.
Up to 3 year
All sexes
Observational
Cincinnati, Ohio, 45229, United States
With every neonatal intensive care unit discharge, physicians and early intervention specialists face a critical challenge: How to counsel parents about their very preterm infant's risk of developing cognitive and motor deficits and accurately assign early intervention therapies. More than 100,000 babies are born very preterm at ≤32 weeks gestational age every year in the United States. Up to 35% of these preterm survivors develop cognitive deficits, and up to 20% develop motor impairment. This places them at high risk for poor educational, health, and social outcomes. Yet reliable diagnosis of cognitive and motor deficits cannot be made until early childhood. This long and unnecessary delay wastes early intervention resources, dilutes the effectiveness of infant stimulation programs, and disrupts parental adaptation. Attempts to address these gaps with conventional neuroimaging and other approaches have failed. Thus, a critical need exists before neonatal discharge, to accurately predict cognitive and motor deficits in individual very preterm infants with the use of novel neuroimaging technologies and established epidemiologic approaches.
The investigators long-term research goal is to elucidate the etiology, pathogenesis, and early prediction of cognitive and motor deficits in order to facilitate preventive early interventions in very preterm infants, resulting in better outcomes. The investigators objectives in this application therefore are to:
The investigators central hypothesis is that objectively quantified DWMA is pathologic, associated with inflammation-associated perinatal illnesses, and an independent predictor of cognitive deficits at 3 years corrected age in very preterm infants. The investigators rationale for this research is that new knowledge investigators expect to have generated will enhance parental counseling, facilitate accurate risk stratification for early intervention therapies, and guide biologically-based strategies for early prevention of DWMA and cognitive and motor deficits in very preterm infants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years of age, corrected for prematurity
Standardized assessment and diagnosis of cerebral palsy at 2 years corrected age
Time frame: 3 years of age, corrected for prematurity
General Conceptual Ability (GCA) score from the Differential Abilities Scale, 2nd Edition
Time frame: 3 years of age, corrected for prematurity
Scores on the Child Behavior Checklist & Early Childhood Behavior Questionnaire - Short Form
Time frame: 2 years of age, corrected for prematurity
Cognitive and language scores on Bayley Scales of Infant and Toddler Development, 3rd Ed
Time frame: 3 years of age, corrected for prematurity
Computerized measures of executive function for preschoolers
Time frame: 3 years of age, corrected for prematurity
General Adaptive Composite score on the Adaptive Behavior Assessment System, 2nd Ed.
Time frame: 3 years of age, corrected for prematurity
Bracken School Readiness Assessment, 3rd Ed.
Children's Hospital Medical Center, Cincinnati
Other
Early Prediction of Cognitive and Motor Deficits Using Advanced MRI in Very Preterm Infants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03093337
Cognition Disorders, Cognitive Dysfunction
Albi, Midi-Pyrénées, France
View Trial DetailsNCT03927833
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Female Urogenital Diseases and Pregnancy Complications
Birmingham, Alabama, United States
View Trial DetailsNCT03241082
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Minneapolis, Minnesota, United States
View Trial DetailsNCT07100353
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Taoyuan, Taiwan
View Trial Details