Premature Infant Clinical Trial
Official title:
Early Prediction of Cognitive and Motor Deficits Using Advanced MRI in Very Preterm Infants
Verified date | February 2024 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Active, not recruiting |
Enrollment | 393 |
Est. completion date | November 2027 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | Good Samaritan Hospital, Ohio, Kettering Health Network, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), University of Cincinnati |
United States,
Chandwani R, Harpster K, Kline JE, Mehta V, Wang H, Merhar SL, Schwartz TL, Parikh NA. Brain microstructural antecedents of visual difficulties in infants born very preterm. Neuroimage Clin. 2022;34:102987. doi: 10.1016/j.nicl.2022.102987. Epub 2022 Mar 9 — View Citation
Chandwani R, Kline JE, Harpster K, Tkach J, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Group. Early micro- and macrostructure of sensorimotor tracts and development of cerebral palsy in high risk infants. Hum Brain Mapp. — View Citation
Chen M, Li H, Fan H, Dillman JR, Wang H, Altaye M, Zhang B, Parikh NA, He L. ConCeptCNN: A novel multi-filter convolutional neural network for the prediction of neurodevelopmental disorders using brain connectome. Med Phys. 2022 May;49(5):3171-3184. doi: — View Citation
Harpster K, Merhar S, Priyanka Illapani VS, Peyton C, Kline-Fath B, Parikh NA. Associations Between Early Structural Magnetic Resonance Imaging, Hammersmith Infant Neurological Examination, and General Movements Assessment in Infants Born Very Preterm. J — View Citation
He L, Li H, Chen M, Wang J, Altaye M, Dillman JR, Parikh NA. Deep Multimodal Learning From MRI and Clinical Data for Early Prediction of Neurodevelopmental Deficits in Very Preterm Infants. Front Neurosci. 2021 Oct 5;15:753033. doi: 10.3389/fnins.2021.753 — View Citation
He L, Li H, Wang J, Chen M, Gozdas E, Dillman JR, Parikh NA. A multi-task, multi-stage deep transfer learning model for early prediction of neurodevelopment in very preterm infants. Sci Rep. 2020 Sep 15;10(1):15072. doi: 10.1038/s41598-020-71914-x. — View Citation
Jain VG, Kline JE, He L, Kline-Fath BM, Altaye M, Muglia LJ, DeFranco EA, Ambalavanan N, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study Investigators. Acute histologic chorioamnionitis independently and directly increases the risk fo — View Citation
Kline JE, Illapani VSP, Li H, He L, Yuan W, Parikh NA. Diffuse white matter abnormality in very preterm infants at term reflects reduced brain network efficiency. Neuroimage Clin. 2021;31:102739. doi: 10.1016/j.nicl.2021.102739. Epub 2021 Jun 25. — View Citation
Kline JE, Yuan W, Harpster K, Altaye M, Parikh NA. Association between brain structural network efficiency at term-equivalent age and early development of cerebral palsy in very preterm infants. Neuroimage. 2021 Dec 15;245:118688. doi: 10.1016/j.neuroimag — View Citation
Lal SK, Nath LS. An atypical case of Vogt-Koyanagi syndrome. J Indian Med Assoc. 1986 Dec;84(12):382-3. No abstract available. — View Citation
Li H, Chen M, Wang J, Illapani VSP, Parikh NA, He L. Automatic Segmentation of Diffuse White Matter Abnormality on T2-weighted Brain MR Images Using Deep Learning in Very Preterm Infants. Radiol Artif Intell. 2021 Feb 3;3(3):e200166. doi: 10.1148/ryai.202 — View Citation
Parikh NA, Sharma P, He L, Li H, Altaye M, Priyanka Illapani VS; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Investigators. Perinatal Risk and Protective Factors in the Development of Diffuse White Matter Abnormality on Term-Equival — View Citation
Parikh NA. Advanced neuroimaging and its role in predicting neurodevelopmental outcomes in very preterm infants. Semin Perinatol. 2016 Dec;40(8):530-541. doi: 10.1053/j.semperi.2016.09.005. Epub 2016 Nov 15. — View Citation
Tamm L, Patel M, Peugh J, Kline-Fath BM, Parikh NA; Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS) Group. Early brain abnormalities in infants born very preterm predict under-reactive temperament. Early Hum Dev. 2020 May;144:104985. do — View Citation
Yuan W, Tamm L, Harpster K, Altaye M, Illapani VSP, Parikh NA. Effects of intraventricular hemorrhage on white matter microstructural changes at term and early developmental outcomes in infants born very preterm. Neuroradiology. 2021 Sep;63(9):1549-1561. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Motor development | Standardized assessment and diagnosis of cerebral palsy at 2 years corrected age | 2 years of age, corrected for prematurity | |
Primary | Cognitive development | General Conceptual Ability (GCA) score from the Differential Abilities Scale, 2nd Edition | 3 years of age, corrected for prematurity | |
Primary | Behavioral development | Scores on the Child Behavior Checklist & Early Childhood Behavior Questionnaire - Short Form | 3 years of age, corrected for prematurity | |
Secondary | 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 | |
Secondary | Executive function | Computerized measures of executive function for preschoolers | 3 years of age, corrected for prematurity | |
Secondary | Behavioral development | General Adaptive Composite score on the Adaptive Behavior Assessment System, 2nd Ed. | 3 years of age, corrected for prematurity | |
Secondary | Pre-academic skills | Bracken School Readiness Assessment, 3rd Ed. | 3 years of age, corrected for prematurity |
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