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Planning the VICTORY (VIsual ComplicaTions Of PrematuRitY) Study

规划 VICTORY（早产儿视觉并发症）研究

基本信息

批准号：
10645471
负责人：
Olaf Dammann
金额：
$ 31.3万
依托单位：
TUFTS UNIVERSITY BOSTON
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-06-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10645471
关键词：
Advisory Committees Area Artificial Intelligence Basic Science Biological Biological Markers Birth Blindness Brain Injuries Child Clinical Clinical Research Cohort Studies Darkness Data Data Analyses Data Collection Databases Developmental Disabilities Disease Elements Etiology Exposure to Extremely low gestational age newborn Feasibility Studies Funding Genetic Goals Image Imaging Device Infection Laboratories Legal Blindness Light Machine Learning Manuals Measurement Measures Mediator Modeling Myopia National Eye Institute National Institute of Neurological Disorders and Stroke Neonatal Neonatal Intensive Care Units Neonatology Observational Study Outcome Outcome Assessment Oxygen Parents Pathogenesis Physiology Placenta Play Pre-Eclampsia Pregnancy Premature Infant Procedures Process Prospective, cohort study Protocols documentation Publications Research Design Research Methodology Research Personnel Retinal Diseases Retinopathy of Prematurity Risk Risk Factors Risk Reduction Role Sepsis Specificity Strabismus Structure Testing Time United States United States National Institutes of Health Visual Work clinical risk cohort data management design equity, diversity, and inclusion experimental study extreme prematurity follow-up high risk imaging biomarker improved infancy innovation instrument intraamniotic infection legally blind member neonatal sepsis neurovascular new therapeutic target novel postnatal premature prenatal recruit retinal imaging social social health determinants sociodemographics systemic inflammatory response working group

项目摘要

PROJECT SUMMARY Retinopathy of prematurity (ROP) is a neurovascular disorder that occurs mainly among extremely preterm infants. The National Eye Institute (NEI) estimates that every year between 400 and 600 children become legally blind due to ROP. The goal of this project is to plan a large, multicenter cohort study designed to gather comprehensive social, clinical, and biomarker data needed to further elucidate the etiology and pathogenesis of ROP and adverse visual outcomes (AVO) in extremely low gestational age newborns (ELGANs, <28weeks gestation). The aims of the project are (1) to finalize the consortium and create expert working groups (WGs) that will tackle the planning tasks in their area of expertise, (2) to develop the study protocol and Manual of Procedures (MOP), and (3) to outline and perform preliminary and feasibility studies. The planned study will have multiple innovative elements, the most important being (a) first multicenter observational study with a focus on ROP/AVO, (b) retina imaging at multiple timepoints after birth, (c) artificial intelligence/machine learning approaches, (d) social determinants of health, (e) pre- and postnatal biomarker measurements, and (f) visual and neurodevelopmental outcome assessment.

项目总结