Early Prediction Study



Status:Recruiting
Healthy:No
Age Range:Any - 3
Updated:3/23/2019
Start Date:September 16, 2016
End Date:July 2022
Contact:Nehal A Parikh, DO, MS
Email:nehal.parikh@cchmc.org
Phone:513-636-7584

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

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:

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.

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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Nehal A Parikh, DO, MS
Phone: 513-636-7584
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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