Documenting and archiving the Safe Passage Study in NICHD Data and Specimen Hub (DASH)
在 NICHD 数据和样本中心 (DASH) 中记录和存档安全通道研究
基本信息
- 批准号:10700943
- 负责人:
- 金额:$ 7.25万
- 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:2022-09-08 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:ATODAlcoholsAnthropometryAnxietyArchivesAuditoryAutopsyBrainCharacteristicsChildChild DevelopmentCigaretteClinicalClinical assessmentsCohort StudiesCommunitiesDataData CollectionData SetDevelopmentDevelopmental BiologyDiagnosisDictionaryDietary intakeDocumentationDysmorphologyEnrollmentEvaluationEventFaceFetal Alcohol ExposureFetal Alcohol Spectrum DisorderFetal StructuresFetusFirst Pregnancy TrimesterFundingGrantGrowthGuidelinesHeadIndian reservationInfantInfant CareInternationalInterventionLaboratoriesLinkLongitudinal cohortManuscriptsMarijuanaMediationMedicalMedical HistoryMental DepressionMethamphetamineMethodologyNational Institute of Child Health and Human DevelopmentNational Institute on Alcohol Abuse and AlcoholismNational Institute on Deafness and Other Communication DisordersNeurologicNewborn InfantParticipantPathologicPathologyPatient Self-ReportPeer ReviewPharmaceutical PreparationsPhysiologicalPhysiologyPlacentaPregnancyPregnant WomenPrenatal carePreparationPrivacyProtocols documentationPublicationsPublishingReportingResearchResearch InstituteResearch PersonnelResourcesRiskSioux FallsSiteSmokingSouth AfricaSouth DakotaSpecimenSudden infant death syndromeTestingTobaccoUnited StatesUnited States National Institutes of HealthVisitWomanalcohol consumption during pregnancyarmclinical research sitecomorbiditydata archivedata de-identificationdata dictionarydata sharingdata warehousedemographicsdietarydisabilitydrinkingfetalinfant deathinterestneurodevelopmentpostnatalprenatalprenatal exposureprimary outcomeprospectivepsychosocialpublic databaserecruitresiliencerespiratorysecondary analysisstillbirthsymposiumtooltribal lands
项目摘要
PROJECT ABSTRACT
The Safe Passage Study is the first prospective, observational, large-scale cohort study to investigate the
effect of prenatal exposure to alcohol, tobacco and drugs on the risk for Sudden Infant Death Syndrome (SIDS),
stillbirth, and Fetal Alcohol Spectrum Disorders (FASD). Participants were recruited from two sites in Cape Town,
South Africa, and five sites in the Northern Plains, United States, including two American Indian Reservations
between 2007 and 2015. In total, the study enrolled 10,088 women, 11,892 pregnancies, and 12,029 fetuses,
followed to 1-year post-delivery. Extensive longitudinal data have been collected during prenatal,
delivery/newborn, and postnatal stages. As such, the Safe Passage Study is an important resource for
researchers interested in prenatal exposures, child physiological and neurological development, and
pathological assessments of SIDS, stillbirth, and FASD. The Safe Passage Study was initiated prior to the NIH
data sharing mandate, thus funds were not available for preparation and archiving of a de-identified dataset. To
facilitate the use of this valuable resource, we propose to make publicly available the Safe Passage Study
datasets via NICHD Data and Specimen Hub (DASH). We will archive and document the existing datasets of
Safe Passage Study, which NICHD sponsored along with NIAAA and NIDCD. More specifically, we will 1.)
prepare and submit PASS self-reported and medical chart abstraction data, such as maternal and infant
characteristics, psychosocial and dietary information, and exposure assessments, to the DASH portal; and 2.)
prepare and submit PASS physiology and pathology data, such as autonomic, respiratory, and brain function in
the fetus and infant, pathology assessments from autopsy and placental evaluation, and neurologic assessments
of the infant to the DASH portal. We will perform data de-identification, create a variable dictionary, prepare
datasets and annotation files using the Data Preparation Tool, and submit the Safe Passage Study to NICHD
DASH. De-identified data sets produced with support from this grant will be available without restriction to
researchers with the exception of data collected on tribal lands, due to sharing restrictions negotiated at the
onset of the study. The shared datasets will enable secondary analysis by the scientific community interested in
the link between prenatal exposures and child development.
项目摘要
安全通道研究是第一项前瞻性、观察性、大规模队列研究,旨在调查
产前接触酒精、烟草和药物对婴儿猝死综合症 (SIDS) 风险的影响,
死产和胎儿酒精谱系障碍 (FASD)。参与者是从开普敦的两个地点招募的,
南非和美国北部平原的五个地点,其中包括两个美洲印第安人保留地
2007 年至 2015 年间。该研究总共招募了 10,088 名女性、11,892 名孕妇和 12,029 名胎儿,
随后至交付后 1 年。在产前、
分娩/新生儿和产后阶段。因此,安全通道研究是重要的资源
对产前暴露、儿童生理和神经发育感兴趣的研究人员,以及
SIDS、死产和 FASD 的病理评估。安全通道研究是在 NIH 之前启动的
数据共享任务,因此没有资金用于准备和归档去识别化数据集。到
促进这一宝贵资源的使用,我们建议公开安全通道研究
通过 NICHD 数据和样本中心 (DASH) 获取数据集。我们将存档并记录现有数据集
安全通道研究,由 NICHD 与 NIAAA 和 NIDCD 共同赞助。更具体地说,我们将 1.)
准备并提交 PASS 自我报告和病历摘要数据,例如母婴
向 DASH 门户提供特征、心理社会和饮食信息以及暴露评估;和 2。)
准备并提交 PASS 生理学和病理学数据,例如自主神经、呼吸和大脑功能
胎儿和婴儿、尸检和胎盘评估的病理学评估以及神经系统评估
将婴儿的信息发送到 DASH 门户。我们将进行数据去标识化,创建变量字典,准备
使用数据准备工具创建数据集和注释文件,并将安全通道研究提交给 NICHD
短跑。在这笔赠款的支持下生成的去识别化数据集将不受限制地提供给
研究人员除了在部落土地上收集的数据外,由于在部落土地上协商的共享限制
研究开始。共享数据集将使感兴趣的科学界能够进行二次分析
产前暴露与儿童发育之间的联系。
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)
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Christine W Hockett其他文献
Christine W Hockett的其他文献
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{{ truncateString('Christine W Hockett', 18)}}的其他基金
Documenting and archiving the Safe Passage Study in NICHD Data and Specimen Hub (DASH)
在 NICHD 数据和样本中心 (DASH) 中记录和存档安全通道研究
- 批准号:
10509779 - 财政年份:2022
- 资助金额:
$ 7.25万 - 项目类别:
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