An observational study in Premature Infant, sponsored by Children's Hospital Medical Center, Cincinnati. Active, not recruiting at 1 site in United States. Open to participants aged Up to 3 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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.
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.
All very preterm infants (≤32 weeks completed gestational age) from a geographically-based population cared for in level III/IV NICUs in Cincinnati/Dayton are eligible. Those with known chromosomal or congenital anomalies affecting the central nervous system or with cyanotic heart disease will be excluded.
Exclusion Criteria:
This is a single group prospective longitudinal, multisite cohort study of very preterm infants born at or below 32 weeks gestational age at birth
Motor development
Standardized assessment and diagnosis of cerebral palsy at 2 years corrected age
Time frame: 2 years of age, corrected for prematurity
Cognitive development
General Conceptual Ability (GCA) score from the Differential Abilities Scale, 2nd Edition
Time frame: 3 years of age, corrected for prematurity
Behavioral development
Scores on the Child Behavior Checklist \& Early Childhood Behavior Questionnaire - Short Form
Time frame: 3 years of age, corrected for prematurity
Cognitive and language deficits at 2years of age
Cognitive and language scores on Bayley Scales of Infant and Toddler Development, 3rd Ed
Time frame: 2 years of age, corrected for prematurity
Executive function
Computerized measures of executive function for preschoolers
Time frame: 3 years of age, corrected for prematurity
Behavioral development
General Adaptive Composite score on the Adaptive Behavior Assessment System, 2nd Ed.
Time frame: 3 years of age, corrected for prematurity
Pre-academic skills
Bracken School Readiness Assessment, 3rd Ed.
Time frame: 3 years of age, corrected for prematurity
Plan to share: No
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati