Neurocognitive outcomes and changes in brain and CSF volume after treatment of post-infectious hydrocephalus in Ugandan infants by shunting or ETV/CPC: a randomized prospective trial

通过分流或 ETV/CPC 治疗乌干达婴儿感染后脑积水后的神经认知结果以及大脑和脑脊液体积的变化：一项随机前瞻性试验

• 批准号: 10677041
• 负责人: Abhaya V Kulkarni
• 金额: $ 49.77万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10677041
• 关键词: 10 year old; Africa; African; Aftercare; Age Months; Anatomy; Brain; Brain imaging; Cauterize; Child; Clinical; Clinical Trials; Cohort Studies; Cost Effectiveness Analysis; Coupled; Data; Development; Diagnosis; Disadvantaged; Endoscopy; Engineering; Etiology; Failure; Funding; Goals; Growth; Health; Hydrocephalus; Image; Imaging technology; Infant; Intracranial Pressure; Lead; Life; Longterm Follow-up; Magnetic Resonance Imaging; Measures; Medical; Medicine; Methods; Neurocognitive; Neurosciences Research; Nursery Schools; Operative Surgical Procedures; Outcome; Outcome Study; Patients; Pediatric Hospitals; Primary Schools; Quality of life; Quality-Adjusted Life Years; Randomized; Randomized Controlled Clinical Trials; Research; Resource-limited setting; School-Age Population; Science; Shunt Device; Site; Structure of choroid plexus; Technology; Treatment Effectiveness; Uganda; United States National Institutes of Health; Universities; Ventriculostomy; X-Ray Computed Tomography; brain volume; cohort; cost; cost effectiveness; empowerment; follow-up; improved; neurodevelopment; prospective; randomized, clinical trials; research and development; success; technology development; trial comparing

The goals of this R01 Renewal are driven by the results of our successfully conducted randomized controlled clinical trial comparing endoscopic third ventriculostomy combined with choroid plexus cauterization (ETV/CPC) to shunt treatment for post-infectious hydrocephalus (PIH, the most common hydrocephalus etiology in Uganda) in infants < 6 months of age (ClinicalTrials.gov NCT01936272, R01HD085853, R21HD068213) at the CURE Children’s Hospital of Uganda (CCHU). The interim outcomes of this study are becoming a landmark in children’s medicine, finding that: a) at up to 24 months, there was no significant difference between ETV/CPC and shunt in regard to failure rate, developmental outcome, and brain growth; b) brain volume, not CSF volume, correlated strongly with developmental outcome; c) successful treatment of the hydrocephalus led to improved brain growth in the first year, which stagnated during the second year. Because almost all of the failures of endoscopic treatment occurred early in the first year of life, we anticipate that the longer term outcomes of hydrocephalus treatment may favor endoscopy if we follow these children through primary school age from 5 to 10 years. Furthermore, our ability to perform much more detailed neurocognitive assessments during this further followup will be much more accurate than during our pre-school assessments. Lastly, we can gather all of our data and perform a much more definitive cost-effectiveness analysis if we can follow this unique cohort for a full 10 years. We have engaged in substantial capacity building during the previous 5 years of support during this clinical trial. We have developed a thriving research unit at the CURE Children’s Hospital of Uganda, enabling high-quality research to be conducted in multiple other NIH funded studies unrelated to this clinical trial (DP1HD086071, R01AI145057, and R01HD096693). Furthermore, since all hydrocephalus treatment requires brain imaging, we have developed a thriving center for sustainable low-field MRI engineering at the Mbarara University of Science and Technology. This present project seeks to follow this unique cohort to 10 years of age, seeking to definitively establish whether endoscopic treatment is more sustainable for infants in the developing world, establish low field MRI as a sustainable imaging technology, and establish the capacity of both the medical and engineering sites in Uganda as independent research and technology development centers for Africa.

此次 R01 更新的目标是由我们成功进行的随机研究的结果驱动的 内镜下第三脑室造口术联合脉络丛的对照临床试验 烧灼（ETV/CPC）以分流治疗感染后脑积水（PIH，最常见的疾病） 乌干达的脑积水病因）小于 6 个月大的婴儿（ClinicalTrials.gov NCT01936272， R01HD085853、R21HD068213），位于乌干达 CURE 儿童医院 (CCHU)。临时 这项研究的结果正在成为儿童医学的一个里程碑，它发现：a) 最多 24 个月，ETV/CPC 和分流之间的故障率没有显着差异， 发育结果和大脑生长； b) 脑容量，而不是脑脊液容量，与 发展成果； c) 成功治疗脑积水可改善大脑发育 第一年，第二年停滞不前。因为几乎所有的内窥镜失败 治疗发生在生命的第一年早期，我们预计长期结果 如果我们跟踪这些儿童直至小学年龄，脑积水治疗可能有利于内窥镜检查 5到10年。此外，我们执行更详细的神经认知评估的能力 在此期间的进一步跟进将比我们的学前评估期间更加准确。最后， 如果可以的话，我们可以收集所有数据并进行更明确的成本效益分析 跟随这个独特的群体整整十年。 在过去 5 年的支持期间，我们进行了大量的能力建设 临床试验。我们在乌干达 CURE 儿童医院建立了一个蓬勃发展的研究单位， 使高质量的研究能够在 NIH 资助的多项与此无关的研究中进行 临床试验（DP1HD086071、R01AI145057 和 R01HD096693）。此外，由于所有脑积水 治疗需要脑部成像，我们开发了一个蓬勃发展的可持续低场 MRI 中心 姆巴拉拉科技大学工程系。 本项目旨在追踪这一独特群体直至 10 岁，力求最终确定 确定内窥镜治疗对于发展中国家的婴儿是否更可持续，建立 低场 MRI 作为一种可持续的成像技术，并建立医学和医学界的能力 乌干达的工程基地作为非洲的独立研究和技术开发中心。

项目成果

Normal childhood brain growth and a universal sex and anthropomorphic relationship to cerebrospinal fluid.

• DOI: 10.3171/2021.2.peds201006
• 发表时间: 2021-10-01
• 期刊: Journal of neurosurgery. Pediatrics
• 作者: Peterson MR;Cherukuri V;Paulson JN;Ssentongo P;Kulkarni AV;Warf BC;Monga V;Schiff SJ
• 通讯作者: Schiff SJ

Preoperative risk and postoperative outcome from subdural fluid collections in African infants with postinfectious hydrocephalus.

• DOI: 10.3171/2021.7.peds21209
• 发表时间: 2022-01-01
• 期刊: JOURNAL OF NEUROSURGERY-PEDIATRICS
• 影响因子: 1.9
• 作者: Lane, Jessica R.;Ssentongo, Paddy;Peterson, Mallory R.;Harper, Joshua R.;Mbabazi-Kabachelor, Edith;Mugamba, John;Ssenyonga, Peter;Onen, Justin;Donnelly, Ruth;Levenbach, Jody;Cherukuri, Venkateswararao;Monga, Vishal;Kulkarni, Abhaya, V;Warf, Benjamin C.;Schiff, Steven J.
• 通讯作者: Schiff, Steven J.

Approaches in cooling of resistive coil-based low-field Magnetic Resonance Imaging (MRI) systems for application in low resource settings.

• DOI: 10.1186/s42490-021-00048-6
• 发表时间: 2021-02-12
• 期刊: BMC biomedical engineering
• 作者: Natukunda F;Twongyirwe TM;Schiff SJ;Obungoloch J
• 通讯作者: Obungoloch J

Assessing the utility of low resolution brain imaging: treatment of infant hydrocephalus.

• DOI: 10.1016/j.nicl.2021.102896
• 发表时间: 2021
• 期刊: NeuroImage. Clinical
• 作者: Harper JR;Cherukuri V;O'Reilly T;Yu M;Mbabazi-Kabachelor E;Mulando R;Sheth KN;Webb AG;Warf BC;Kulkarni AV;Monga V;Schiff SJ
• 通讯作者: Schiff SJ

An Unmatched Radio Frequency Chain for Low-Field Magnetic Resonance Imaging.

用于低场磁共振成像的无与伦比的射频链。

• DOI: 10.3389/fphy.2021.727536
• 发表时间: 2021
• 期刊: Frontiers in physics
• 影响因子: 3.1
• 作者: Harper,JoshuaR;Zárate,Cristhian;Krauch,Federico;Muhumuza,Ivan;Molina,Jorge;Obungoloch,Johnes;Schiff,StevenJ
• 通讯作者: Schiff,StevenJ