Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)

NCT03345069 | Active Not Recruiting

• 3 other identifiers: CIN_EARLYPREDICTION_0015R01NS0942005R01NS096037
• Study Type: observational
• Target: 393
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Cognitive and language deficits at 2years of age

  2 years of age, corrected for prematurity

• Executive function

  3 years of age, corrected for prematurity

• Behavioral development

  3 years of age, corrected for prematurity

• Pre-academic skills

  3 years of age, corrected for prematurity

Study Arms (1)

Infants born very preterm

This is a single group prospective longitudinal, multisite cohort study of very preterm infants born at or below 32 weeks gestational age at birth

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All very preterm infants (≤32 weeks completed gestational age) from a geographically-based population cared for in level III/IV NICUs in Cincinnati/Dayton are eligible. Those with known chromosomal or congenital anomalies affecting the central nervous system or with cyanotic heart disease will be excluded.

You may qualify if:

• 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.

You may not qualify if:

• Infants with known chromosomal or congenital anomalies affecting the central nervous system or with cyanotic heart disease.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Cincinnati: collaborator
• Good Samaritan Hospital, Ohio: collaborator
• Kettering Health Network: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (15)

• 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.

  PMID: 27863706 BACKGROUND

• 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.

  PMID: 32934282 BACKGROUND

• 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. doi: 10.1016/j.earlhumdev.2020.104985. Epub 2020 Mar 9.

  PMID: 32163848 RESULT

• 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-Equivalent Age Magnetic Resonance Imaging in Infants Born Very Preterm. J Pediatr. 2021 Jun;233:58-65.e3. doi: 10.1016/j.jpeds.2020.11.058. Epub 2020 Nov 28.

  PMID: 33259857 RESULT

• 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. 2021 Oct 1;42(14):4708-4721. doi: 10.1002/hbm.25579. Epub 2021 Jul 29.

  PMID: 34322949 RESULT

• 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: 10.1002/mp.15545. Epub 2022 Mar 14.

  PMID: 35246986 RESULT

• Lal SK, Nath LS. An atypical case of Vogt-Koyanagi syndrome. J Indian Med Assoc. 1986 Dec;84(12):382-3. No abstract available.

  PMID: 3585016 RESULT

• 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 for brain abnormalities seen on magnetic resonance imaging in very preterm infants. Am J Obstet Gynecol. 2022 Oct;227(4):623.e1-623.e13. doi: 10.1016/j.ajog.2022.05.042. Epub 2022 May 26.

  PMID: 35644247 RESULT

• 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.neuroimage.2021.118688. Epub 2021 Nov 7.

  PMID: 34758381 RESULT

• 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.2021.753033. eCollection 2021.

  PMID: 34675773 RESULT

• 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.

  PMID: 35290855 RESULT

• 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.

  PMID: 34237685 RESULT

• 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.2021200166. eCollection 2021 May.

  PMID: 34142089 RESULT

• 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. doi: 10.1007/s00234-021-02708-9. Epub 2021 Apr 8.

  PMID: 33830309 RESULT

• 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 Pediatr. 2021 May;232:80-86.e2. doi: 10.1016/j.jpeds.2020.12.056. Epub 2021 Jan 13.

  PMID: 33453201 RESULT

Related Links

• Early Prediction Study website

MeSH Terms

Conditions

Premature Birth; Cerebral Palsy; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nehal A Parikh, DO, MS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 17, 2017
• Study Start: September 16, 2016
• Primary Completion: December 31, 2024
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)