Skip to content

Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03345069
Enrollment
393
Registered
2017-11-17
Start date
2016-09-16
Completion date
2027-11-30
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infant

Keywords

Premature, Magnetic resonance imaging (MRI), Neurodevelopmental impairment, Cerebral Palsy, Cognitive Impairment, Diffusion MRI, Functional MRI, Infant, Magnetic resonance spectroscopy

Brief summary

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

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: 1. Identify the clinical antecedents of objectively diagnosed diffuse white matter abnormality (DWMA). 2. Associate DWMA with pathologic changes on neuroimaging. 3. Predict cognitive and behavioral deficits at 3 years of age using objectively diagnosed DWMA in a geographic cohort of very preterm infants. 4. 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.

Interventions

None listed

Sponsors

University of Cincinnati
CollaboratorOTHER
Good Samaritan Hospital, Ohio
CollaboratorOTHER
Kettering Health Network
CollaboratorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Motor development2 years of age, corrected for prematurityStandardized assessment and diagnosis of cerebral palsy at 2 years corrected age
Cognitive development3 years of age, corrected for prematurityGeneral Conceptual Ability (GCA) score from the Differential Abilities Scale, 2nd Edition
Behavioral development3 years of age, corrected for prematurityScores on the Child Behavior Checklist & Early Childhood Behavior Questionnaire - Short Form

Secondary

MeasureTime frameDescription
Cognitive and language deficits at 2years of age2 years of age, corrected for prematurityCognitive and language scores on Bayley Scales of Infant and Toddler Development, 3rd Ed
Pre-academic skills3 years of age, corrected for prematurityBracken School Readiness Assessment, 3rd Ed.
Executive function3 years of age, corrected for prematurityComputerized measures of executive function for preschoolers
Behavioral development3 years of age, corrected for prematurityGeneral Adaptive Composite score on the Adaptive Behavior Assessment System, 2nd Ed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026