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NCT Number: NCT03345069

Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)

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.

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This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Motor development

    Time frame: 2 years of age, corrected for prematurity

    Standardized assessment and diagnosis of cerebral palsy at 2 years corrected age

  2. Cognitive development

    Time frame: 3 years of age, corrected for prematurity

    General Conceptual Ability (GCA) score from the Differential Abilities Scale, 2nd Edition

  3. Behavioral development

    Time frame: 3 years of age, corrected for prematurity

    Scores on the Child Behavior Checklist & Early Childhood Behavior Questionnaire - Short Form

Secondary outcomes

  1. Cognitive and language deficits at 2years of age

    Time frame: 2 years of age, corrected for prematurity

    Cognitive and language scores on Bayley Scales of Infant and Toddler Development, 3rd Ed

  2. Executive function

    Time frame: 3 years of age, corrected for prematurity

    Computerized measures of executive function for preschoolers

  3. Behavioral development

    Time frame: 3 years of age, corrected for prematurity

    General Adaptive Composite score on the Adaptive Behavior Assessment System, 2nd Ed.

  4. Pre-academic skills

    Time frame: 3 years of age, corrected for prematurity

    Bracken School Readiness Assessment, 3rd Ed.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Good Samaritan Hospital, Ohio
  • Kettering Health Network
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)
  • University of Cincinnati

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2027
First posted
Nov 17, 2017
Registry last updated
Feb 7, 2024

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.

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