RFA-DD-18-001 Birth Defects Study To Evaluate Pregnancy exposures (BD-STEPS) II Core & Component B Steps -Stillbirth

A组分 在美国，每100个婴儿中就有3个出生时就有结构性缺陷。出生缺陷是美国婴儿死亡的主要原因 以及世界范围内。患有出生缺陷而存活下来的儿童通常会经历生活质量下降，并对社会和 经济负担。虽然出生缺陷是一个重大的公共卫生问题，但临床和公共卫生努力预防大多数出生缺陷 是有限的。缺乏关于大多数非综合征性出生缺陷病因的证据是建立预防措施的主要障碍。 程序。1997年，创建了国家出生缺陷预防研究(NBDPS)，以调查这些复杂的病因。使用阶段化 在NBDPS之外，疾控中心在NBDPS调查结果的基础上发起了一项新的倡议-出生缺陷研究，以评估怀孕暴露 (SD-STEP)。阿肯色州出生缺陷研究和预防中心，参加NBDPS 16年，参加8D 第一步致力于了解出生缺陷的原因，并欢迎有机会继续“为证据基础作出贡献” 这将有助于制定有效的预防战略。我们处于有利地位，可以在阿肯色州中心的基础上通过 确定怀孕早期可能需要早期预防的产妇暴露情况。阿肯色州中心的长期目标是 预防或显著减少出生缺陷的发生。因此，我们建议确定可改变的早孕暴露情况， 通过参与BO-Steps II，发现导致出生的基因-环境相互作用，减少选定出生缺陷的发生 支持从NBDPS和BO-STEP收集的生物样本的高通量基因组和表观基因组分析的缺陷 参与者，并通过培训和指导初级研究人员在数据分析方面帮助培养未来几代出生缺陷研究人员， 稿件准备等与学习有关的活动。通过我们的研究，我们将在建立临床和公共服务方面保持领先地位 预防出生缺陷的健康战略。 组件 全球每年发生3200万例死产。在美国和其他发达国家，死产在很大程度上是一种研究不足的围产儿结局 尽管它是最常见的不良妊娠结局之一，占所有围产儿死亡的一半。2006年，最近一次 根据美国现有的数据，每1000名活产儿中有6.05名死产，加上胎儿死亡，这一比例远远高于许多高收入国家 还有美国。2020年健康人目标为5.6(每千名活产胎儿死亡)的胎儿死亡率。死产的确认率很低 在美国和大多数发达和发展中的国家。关于死产发生率的最新全国性数据是2006年以来的 强调目前在确定和监测这一未得到充分研究的围产儿结局方面基础设施不足。这个 疾病控制和预防中心(CDC)通过两项试点研究证明，扩大现有的生育方法 用于监测死产的缺陷登记处是监测死产的一种可行且具有成本效益的方法。疾控中心宣布了一项倡议，出生 评估妊娠暴露的缺陷研究(BO-STEPS)II死胎研究，将侧重于进行病例对照研究以阐明 死产的可修改风险因素，使用出生缺陷研究和预防基础设施作为基础 监视和研究。阿肯色州中心的长期目标是预防或显著减少出生缺陷和 不良妊娠结局。我们建议利用我们在阿肯色州基于人口的积极的死产监测系统来识别新的 可改变的妊娠暴露，减少死产的发生。通过我们的研究，我们将在建立 预防出生缺陷和死产的健康策略。 相关性(请参阅说明)： A组分：出生缺陷是婴儿死亡的主要原因。在美国出生的婴儿中，每100人中就有3人有严重的结构性出生缺陷，造成 严重的公共卫生问题。基于我们之前在NBDPS和BD Steps I方面的经验，阿肯色州中心将继续确定 孕妇在怀孕早期的暴露可能是可以早期预防的，极大地减少了出生缺陷的发生。疾控中心续建工程 资金将使该中心在制定预防出生缺陷的临床和公共卫生战略方面保持领导作用。 构成部分B：死产占围产儿死亡总数的一半，是一个重大的公共卫生问题。大多数死产的原因尚不清楚。在基础上建设 我们以前使用NBDPS和BO的经验--第一步，我们将继续确定怀孕早期母亲可能受到早期感染的情况 预防，重点是大幅减少死产的发生。疾控中心继续提供资金将使阿肯色州中心保持领先地位 在制定防止死产的战略方面。

COMPONENT A Three out of every 100 babies in the US are born with a structural birth defects. Birth defects are a leading cause of infant mortality in the US and worldwide. Children who survive with birth defects often experience a diminished quality of life and impose a substantial social and economic burden. Although birth defects pose a significant public health problem, clinical and public heath efforts to prevent most birth defects are limited. The lack of evidence regarding etiology of most nonsyndromic birth defects represents a major barrier in establishing prevention programs. In 1997, the National Birth Defects Prevention Study (NBDPS) was created to investigate these complex etiologies. With the phasing out of the NBDPS, the CDC initiated a new initiative building on the NBDPS findings -the Birth Defects STudy to Evaluate Pregnancy exposures (SD-STEPS). The Arkansas Center f~r Birth Defects Research and Prevention, a participant in the NBDPS for 16 years and a participant in 8D STEPS I, is dedicated to understani:ling the causes of birth defects and welcomes the opportunity to continue to"contribute to an evidence base that will facilitate development of effective prevention strategies. We are well positioned to build on the foundation of the Arkansas Center by identifying maternal exposures in early pregnancy that may be amenable to early prevention. The long-term goal of the Arkansas Center is to prevent or significantly reduce the occurrence of birth defects. We propose, therefore, to identify modifiable early pregnancy exposures that may decrease the occurrence of selected birth defects by participating in BO-STEPS II, discovering gene-environment interactions that lead to birth defects by supporting high-throughput genomic and epigenomlc analyses of biological samples collected from NBDPS and BO-STEPS participants, and helping develop future generations of birth-defect researchers by training and mentoring junior researchers in data analysis, manuscript preparation, and other study-related activities. Through our studies, we will maintain a leading role in establishing clinical and public health strategies to prevent birth defects. COMPONENTS Each year 32 million stillbirths occur globally. In the US and other developed countries, stillbirth is a largely under-studied perinatal outcome despite being one of the most common adverse pregnancy outcomes, accounting for one-half of all perinatal deaths. In 2006, the most recent data available for the US, stillbirths occurred In 6.05 of every 1,000 live births plus fetal deaths, much higher than many high-income countries and the US. Healthy People 2020 Objective of 5.6 (per 1,000 live births+ fetal deaths) for fetal mortality rates. Stillbirths are poorly ascertained in the US and most developed and developlng countries. The most recent national data available on stillbirth prevalence is from 2006 which underscores the insufficient infrastructure currently in place for ascertainment and monitoring of this understudied perinatal outcome. The Centers for Disease Control and Prevention (CDC) demonstrated through two pilot studies that expanding the current methods of existing birth defects registries for stillbirth surveillance is a viable and cost-effective method for surveillance of stillbirths. CDC announced an initiative, Birth Defects Study to Evaluate Pregnancy exposures (BO-STEPS) II Stillbirth study, which will focus on conducting a case-control study to elucidate modifiable risk factors for stillbirths, using the Centers for Birth Defects Research and Prevention infrastructure as the foundation for surveillance and research. The Arkansas Center's long-term goal is to prevent or significantly reduce the occurrence of birth defects and adverse pregnancy outcomes. We propose to utilize our population-based, active surveillance system of stillbirths in Arkansas to Identify novel modifiable pregnancy exposures that decrease the occurrence of stillbirths. Through our studies, we will maintain a leading role in establishing health strate1;1ies to prevent birth defects and stillbirths. RELEVANCE (See instructions): COMPONENT A: Birth defects are a leadlng cause of infant mortality. Three out of every 100 babies born in the US have a major structural birth defects, posing a significant public health problem. Building on our previous experience with the NBDPS and BD STEPS I, the Arkansas Center is positioned to continue Identifying maternal exposures in early pregnancy that may be amenable to early prevention, greatly reducing the occurrence of birth defects. Continuation of CDC Center funding will enable the Center to maintain a leading role in establishing clinical and public health strategies to prevent birth defects. COMPONENT B: Stillbirths account for half of all perinatal deaths, posing a significant public health problem. The cause of most stillbirths is unknown. Building on our previous experience with the NBDPS and BO-STEPS I, we will continue to identify maternal exposures in early pregnancy that may be amenable to early prevention and focus on greatly reducing the occurrence of stillbirths. Continuation of CDC Center funding will enable the Arkansas Center to maintain a leading role in establishing strategies to prevent stillbirths.