Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Identify the clinical antecedents of objectively diagnosed diffuse white matter abnormality (DWMA). Associate DWMA with pathologic changes on neuroimaging. Predict cognitive and behavioral deficits at 3 years of age using objectively diagnosed DWMA in a geographic cohort of very preterm infants. To predict motor impairment, especially cerebral palsy at 24 months corrected age. 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.

Official Title
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Early Prediction of Cognitive and Motor Deficits Using Advanced MRI in Very Preterm Infants

Conditions
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Premature Infant

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized infants born at ≤32 weeks completed gestational age that are being cared for in all three level III/IV NICUs from the Greater Cincinnati area. Exclusion Criteria: Infants with known chromosomal or congenital anomalies affecting the central nervous system or with cyanotic heart disease.

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants born very preterm<br>This is a single group prospective longitudinal, multisite cohort study of very preterm infants born at or below 32 weeks gestational age at birth | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor development | Standardized assessment and diagnosis of cerebral palsy at 2 years corrected age | 2 years of age, corrected for prematurity | 
| Cognitive development | General Conceptual Ability (GCA) score from the Differential Abilities Scale, 2nd Edition | 3 years of age, corrected for prematurity | 
| Behavioral development | Scores on the Child Behavior Checklist & Early Childhood Behavior Questionnaire - Short Form | 3 years of age, corrected for prematurity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive and language deficits at 2years of age | Cognitive and language scores on Bayley Scales of Infant and Toddler Development, 3rd Ed | 2 years of age, corrected for prematurity | 
| Executive function | Computerized measures of executive function for preschoolers | 3 years of age, corrected for prematurity | 
| Behavioral development | General Adaptive Composite score on the Adaptive Behavior Assessment System, 2nd Ed. | 3 years of age, corrected for prematurity | 
| Pre-academic skills | Bracken School Readiness Assessment, 3rd Ed. | 3 years of age, corrected for prematurity | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature, Magnetic resonance imaging (MRI), Neurodevelopmental impairment, Cerebral Palsy, Cognitive Impairment, Diffusion MRI, Functional MRI, Infant, Magnetic resonance spectroscopy