Consortium Of MRI Biomarkers In Neonatal Encephalopathy (COMBINE)

新生儿脑病 MRI 生物标志物联盟 (COMBINE)

基本信息

  • 批准号:
    10614588
  • 负责人:
  • 金额:
    $ 88.39万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2022
  • 资助国家:
    美国
  • 起止时间:
    2022-05-01 至 2025-04-30
  • 项目状态:
    未结题

项目摘要

Abstract Hypoxic Ischemic Encephalopathy (HIE) is a brain injury occurring in ~5/1000 newborns. In 2005, the NIH Neonatal Research Network (NRN) established therapeutic hypothermia (TH), cooling patients in the first 6 postnatal hours to 33-34°C for 72 hours, as the standard treatment for HIE in high-income countries. However, many patients still experience adverse outcomes (death or cognitive Bayley Scales of Infant Development <85) by 18-22 months. Thus, from 2008 to 2015, the NRN tested if deeper, longer, or later TH further reduced adverse outcomes, with two trials in 21 sites. Unfortunately, results were inconclusive and further progress has been slow, largely because adverse outcomes cannot be reliably assessed until 18-22 months. To expedite therapeutic innovations and assess the impact of novel therapies in a more timely manner, there is an urgent but unmet need to establish a neonatal biomarker of 18-22 month adverse outcomes. To address this gap, the NRN developed such a biomarker using neuroradiological expert scoring of brain injury on clinically acquired neonatal brain magnetic resonance images (MRIs), known as the NRN MRI score. In one dataset with one reader, sensitivity/specificity for adverse outcomes was 81%/78%. However, in another dataset with two readers, the inter-reader agreement was only moderate and specificity for adverse outcomes was only 56-69%. Questions arise for whether this subjective and time-consuming scoring system is reliable or fully characterizes complex HIE injury patterns. Also in many countries, there are no experts available to perform MRI scoring. Finally, important clinical data elements such as birth weight, sex, APGAR scores, socioeconomic status, and aspects of the clinical exam are not fully integrated into the scoring system. Our overall hypothesis is that Artificial Intelligence (AI) algorithms on neonatal brain MRI and clinical data elements can provide higher sensitivity and specificity than the expert NRN MRI scores in predicting adverse HIE outcomes by 18-22 months. Our R61 Aims are as follows: Aim 1, Compile a large HIE dataset (N=430) from two completed NRN multi-site HIE trials; Aim 2, Develop an AI biomarker of outcome using neonatal brain MRI, and compare with NRN scores with Aim 2a focusing on MRI injury patterns and Aim 2b focusing on whole brain MRI signal intensity patterns; and Aim 3, Develop an AI biomarker of outcome combining clinical and MRI data, and compare with NRN scores. Go/No- Go criteria for the R33 is if at least one biomarker (2a, 2b, or 3) outperforms NRN MRI scores in our N=430 cohort (p<0.05; DeLong Test of AUC). The R33 Aim 4 is to further evaluate accuracy and reliability in a new cohort (N=231). Deliverables: Publicly released data and the AI software. Impact: A brain MRI and clinical AI- powered neonatal prognostic biomarker could expedite therapeutic innovations in future HIE trials worldwide.
摘要

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

Patricia Ellen Grant其他文献

Design and rationale of “Antecedents and correlates of well-being in young adults with congenital heart disease in the Boston Circulatory Arrest Study (BCAS-adult)”
“波士顿循环骤停研究(BCAS-成人)中先天性心脏病青年成人幸福感的前因和相关因素”的设计与原理
  • DOI:
    10.1016/j.ahj.2025.05.012
  • 发表时间:
    2025-11-01
  • 期刊:
  • 影响因子:
    3.500
  • 作者:
    Michelle Gurvitz;Alexandra Roseman;Lori Sahakian;Johanna Calderon;Ai Wern Chung;Donna Duva;Borjan Gagoski;Clare Hobson;Jee Won Kang;Adrienne Kovacs;Patricia Ibeziako;Michael Rivkin;David Bellinger;David Wypij;Patricia Ellen Grant;Jane W. Newburger
  • 通讯作者:
    Jane W. Newburger

Patricia Ellen Grant的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

{{ truncateString('Patricia Ellen Grant', 18)}}的其他基金

Consortium Of MRI Biomarkers In Neonatal Encephalopathy (COMBINE)
新生儿脑病 MRI 生物标志物联盟 (COMBINE)
  • 批准号:
    10436592
  • 财政年份:
    2022
  • 资助金额:
    $ 88.39万
  • 项目类别:
Exploring the relationship between advanced multimodal brain MRI phenotypes, genes and cognitive outcome in adults with CHD
探索成人先心病患者高级多模态脑 MRI 表型、基因和认知结果之间的关系
  • 批准号:
    10371086
  • 财政年份:
    2021
  • 资助金额:
    $ 88.39万
  • 项目类别:
Exploring the relationship between advanced multimodal brain MRI phenotypes, genes and cognitive outcome in adults with CHD
探索成人先心病患者高级多模态脑 MRI 表型、基因和认知结果之间的关系
  • 批准号:
    10579297
  • 财政年份:
    2021
  • 资助金额:
    $ 88.39万
  • 项目类别:
Neurobiology of Mothering and Infant Stress
母亲和婴儿压力的神经生物学
  • 批准号:
    9270056
  • 财政年份:
    2015
  • 资助金额:
    $ 88.39万
  • 项目类别:
Neurobiology of Mothering and Infant Stress
母亲和婴儿压力的神经生物学
  • 批准号:
    8818212
  • 财政年份:
    2015
  • 资助金额:
    $ 88.39万
  • 项目类别:
Neonatal Hypoxic Ischemic Encephalopathy: Potential of Innovative NIRS to Optimize Hypothermia
新生儿缺氧缺血性脑病:创新 NIRS 优化低温的潜力
  • 批准号:
    10632024
  • 财政年份:
    2014
  • 资助金额:
    $ 88.39万
  • 项目类别:
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
围产期脑损伤:创新 NIRS 优化低温治疗的潜力
  • 批准号:
    8853307
  • 财政年份:
    2014
  • 资助金额:
    $ 88.39万
  • 项目类别:
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
围产期脑损伤:创新 NIRS 优化低温治疗的潜力
  • 批准号:
    9093827
  • 财政年份:
    2014
  • 资助金额:
    $ 88.39万
  • 项目类别:
Neonatal Hypoxic Ischemic Encephalopathy: Potential of Innovative NIRS to Optimize Hypothermia
新生儿缺氧缺血性脑病:创新 NIRS 优化低温的潜力
  • 批准号:
    10446683
  • 财政年份:
    2014
  • 资助金额:
    $ 88.39万
  • 项目类别:
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
围产期脑损伤:创新 NIRS 优化低温治疗的潜力
  • 批准号:
    8639152
  • 财政年份:
    2014
  • 资助金额:
    $ 88.39万
  • 项目类别:

相似海外基金

Planar culture of gastrointestinal stem cells for screening pharmaceuticals for adverse event risk
胃肠道干细胞平面培养用于筛选药物不良事件风险
  • 批准号:
    10707830
  • 财政年份:
    2023
  • 资助金额:
    $ 88.39万
  • 项目类别:
Hospital characteristics and Adverse event Rate Measurements (HARM) Evaluated over 21 years.
医院特征和不良事件发生率测量 (HARM) 经过 21 年的评估。
  • 批准号:
    479728
  • 财政年份:
    2023
  • 资助金额:
    $ 88.39万
  • 项目类别:
    Operating Grants
Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV)
分析 ECOG-ACRIN 不良事件数据,以优化在不断发展的癌症治疗范式 (EVOLV) 背景下纵向耐受性评估的策略
  • 批准号:
    10884567
  • 财政年份:
    2023
  • 资助金额:
    $ 88.39万
  • 项目类别:
AE2Vec: Medical concept embedding and time-series analysis for automated adverse event detection
AE2Vec:用于自动不良事件检测的医学概念嵌入和时间序列分析
  • 批准号:
    10751964
  • 财政年份:
    2023
  • 资助金额:
    $ 88.39万
  • 项目类别:
Understanding the real-world adverse event risks of novel biosimilar drugs
了解新型生物仿制药的现实不良事件风险
  • 批准号:
    486321
  • 财政年份:
    2022
  • 资助金额:
    $ 88.39万
  • 项目类别:
    Studentship Programs
Pediatric Adverse Event Risk Reduction for High Risk Medications in Children and Adolescents: Improving Pediatric Patient Safety in Dental Practices
降低儿童和青少年高风险药物的儿科不良事件风险:提高牙科诊所中儿科患者的安全
  • 批准号:
    10676786
  • 财政年份:
    2022
  • 资助金额:
    $ 88.39万
  • 项目类别:
Pediatric Adverse Event Risk Reduction for High Risk Medications in Children and Adolescents: Improving Pediatric Patient Safety in Dental Practices
降低儿童和青少年高风险药物的儿科不良事件风险:提高牙科诊所中儿科患者的安全
  • 批准号:
    10440970
  • 财政年份:
    2022
  • 资助金额:
    $ 88.39万
  • 项目类别:
Improving Adverse Event Reporting on Cooperative Oncology Group Trials
改进肿瘤学合作组试验的不良事件报告
  • 批准号:
    10642998
  • 财政年份:
    2022
  • 资助金额:
    $ 88.39万
  • 项目类别:
Planar culture of gastrointestinal stem cells for screening pharmaceuticals for adverse event risk
胃肠道干细胞平面培养用于筛选药物不良事件风险
  • 批准号:
    10482465
  • 财政年份:
    2022
  • 资助金额:
    $ 88.39万
  • 项目类别:
Expanding and Scaling Two-way Texting to Reduce Unnecessary Follow-Up and Improve Adverse Event Identification Among Voluntary Medical Male Circumcision Clients in the Republic of South Africa
扩大和扩大双向短信,以减少南非共和国自愿医疗男性包皮环切术客户中不必要的后续行动并改善不良事件识别
  • 批准号:
    10191053
  • 财政年份:
    2020
  • 资助金额:
    $ 88.39万
  • 项目类别:
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了