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Prevention of Developmental Delay and Xylitol (PDDaX) Study

预防发育迟缓和木糖醇 (PDDaX) 研究

基本信息

批准号：
10447994
负责人：
Gregory Charles Valentine
金额：
$ 16.01万
依托单位：
UNIVERSITY OF WASHINGTON
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：
2022-06-09 至 2027-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10447994
关键词：
18 year old 6 year old Address Africa South of the Sahara Age Assessment tool Birth Birth Rate Caring Child Cluster randomized trial Consumption Country Data Databases Dental Dental caries Detection Development Developmental Delay Disorders Diagnostic tests Enrollment Exposure to Feasibility Studies Follow-Up Studies Future Gold Grant Infection Inflammation Inflammatory Infrastructure Institution Intervention Intervention Studies Knowledge Lead Learning Life Link Long-Term Effects Malawi Mastication Measures Mental Depression Mentors Mothers Neonatal Neurodevelopmental Disability Outcome Outcomes Research Patients Periodontal Diseases Periodontitis Pregnancy Pregnant Women Premature Birth Preparation Prevention Quality of life Reference Standards Research Research Design Research Infrastructure Research Proposals Resource-limited setting Risk Factors Sampling Screening procedure Sensitivity and Specificity Sugar Substitute Testing Time Training Translating Treatment Cost Validation Vulnerable Populations Woman Writing Xylitol aged analytical method autism spectrum disorder base career child battery cost cost effective data management design diagnostic tool diagnostic value early pregnancy efficacy testing epidemiology study global health health disparity improved infrastructure development innovation intervention cost low and middle-income countries mortality neonatal health neonatal outcome neonate neurodevelopment novel offspring perinatal intervention premature prenatal prenatal exposure preterm newborn prevent screening sex skills systemic inflammatory response tool xylitol gum

项目摘要

Globally, 15 million preterm births occur annually, with the majority born in low- and middle-income countries. Prematurity is a leading cause of both under-5 mortality and future neurodevelopmental delay. A long- established link between periodontal disease and preterm birth exists, yet common dental interventions such as scaling and planing fail to prevent preterm birth. Xylitol, a sugar substitute commonly found in gum products, prevents caries and periodontitis with presumed dampening of local and systemic inflammation, a risk factor for neurodevelopmental delay in offspring. We recently completed a cluster-randomized trial in Malawi designed to test the efficacy of xylitol gums to prevent preterm birth and immediate neonatal outcomes. This follow-up study proposal seeks to meaningfully advance our findings by evaluating if exposure to xylitol gum administered preconception or during early pregnancy improves neurodevelopmental outcomes in offspring (up to 6 years of age). Specifically, we will test the hypothesis by formally evaluating whether chewing xylitol gum prevents adverse neurodevelopmental outcomes by leveraging subjects from the Prevention of Prematurity and Xylitol (PPaX) Trial that enrolled 10,404 pregnant women in Malawi from 2015-2019. The Specific Aims of the research are to: 1) Evaluate the sensitivity and specificity of the MDAT as compared to the KABC-II neurodevelopment diagnostic tool in assessing neurodevelopmental delay of formerly term children aged 4-6 years of age; 2) Evaluate the sensitivity and specificity of the MDAT as compared to the KABC- II in assessing neurodevelopmental delay of formerly preterm children aged 4-6 years of age; 3) Determine the impact of xylitol gum exposure during pregnancy on the neurodevelopmental outcomes of 200 sex-matched term born children (100 controls, 100 xylitol) and 200 preterm born children (100 controls, 100 xylitol). Validating the MDAT by comparing it to the KABC-II neurodevelopmental assessment in former preterm and term neonates in Malawi will allow for more efficient, cost-effective studies in the future and build capacity in low-resourced settings to identify children with neurodevelopmental delay more easily and provide more timely intervention. If xylitol use during pregnancy is found to prevent neurodevelopmental delay in offspring, this low-cost solution will prove to be a game-changer in preventing neurodevelopmental delay worldwide. Proposed Career and Learning Objectives are to: 1) Attain advanced skills in epidemiology, study design, data management, and analytic methods to correctly implement research focusing on evaluating neonatal outcomes in settings of health disparities, and 2) Enhance skills in database development, scientific writing, presentations, and grant preparation, and 3) Attain advanced skills, including neurodevelopmental test selection, examiner training and oversight, test interpretation and knowledge needed to conduct rigorous neurodevelopmental outcomes research. These skills will facilitate the applicant’s cutting-edge research on perinatal interventions to improve neonatal health and future neurodevelopmental outcomes in the most vulnerable populations.

在全球范围内，每年发生1500万例早产，其中大多数出生在低收入和中等收入国家。早产是5岁以下儿童死亡和未来神经发育迟缓的主要原因。很长的- 牙周病和早产之间的联系已经建立，但常见的牙科干预措施，刮除和刨平不能防止早产。木糖醇是口香糖产品中常见的一种糖替代品，预防龋齿和牙周炎，并假定抑制局部和全身炎症，这是后代神经发育迟缓。我们最近在马拉维完成了一项随机分组试验，测试木糖醇口香糖预防早产和新生儿即刻结局的功效。本随访研究一项提案旨在通过评估暴露于木糖醇口香糖是否给药，怀孕前或怀孕早期改善后代的神经发育结果（长达6年）。年龄）。具体来说，我们将通过正式评估咀嚼木糖醇口香糖是否能预防通过利用来自预防早产和木糖醇的受试者，（PPaX）试验于2015年至2019年在马拉维招募了10，404名孕妇。本研究的具体目的是：1）评价MDAT的敏感性和特异性， KABC-II神经发育诊断工具在评估神经发育迟缓的前期 4-6岁儿童; 2）评价MDAT与KABC相比的敏感性和特异性- II评估4-6岁早产儿的神经发育迟缓; 3）确定妊娠期暴露于木糖醇口香糖对200例性别匹配足月儿神经发育结局的影响出生的儿童（100个对照，100个木糖醇）和200个早产的儿童（100个对照，100个木糖醇）。验证 MDAT通过将其与KABC-II神经发育评估进行比较，对前早产儿和足月新生儿进行评估马拉维将允许今后开展更有效、更具成本效益的研究，并在资源匮乏的环境中建设能力更容易识别神经发育迟缓的儿童，并提供更及时的干预。如果使用木糖醇在怀孕期间，发现可以防止后代神经发育迟缓，这种低成本的解决方案将被证明，在全球范围内预防神经发育迟缓的游戏规则改变者。建议的职业和学习目标是：1）获得流行病学，研究设计，数据管理和分析方法，以正确实施以评估新生儿结局为重点的研究在健康差距的背景下，2）提高数据库开发，科学写作，演示文稿，和赠款准备，和3）达到先进的技能，包括神经发育测试选择，考官培训和监督，测试解释和进行严格的神经发育所需的知识成果研究。这些技能将有助于申请人对围产期干预措施的前沿研究，改善新生儿健康和最脆弱人群未来的神经发育结果。