Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 主要终点
- Stillbirth Due to Invasive Group B Streptococcus
研究概览
简要总结
The goal of this registry is to collect and store important medical and non-health information on children from 0 to 18 years of age affected by early- (up to 24 hours after birth) and late-onset (up to 90 days after birth) invasive Group B Streptococcus (iGBS) and their families. Data collected from families of children affected by perinatal iGBS will support further research to understand the short- and long-term impact of iGBS disease on affected children and its impact on their families. Participants will be invited to complete obstetric and pregnancy-related questionnaires as well as validated neurodevelopmental surveys at various timepoints throughout their participation in the registry.
详细描述
BACKGROUND Group B Streptococcus (GBS) is a bacterial pathogen and the leading cause of severe neonatal infections and neonatal mortality, maternal morbidity, and adverse pregnancy outcomes globally. If not treated, Group B streptococcus (GBS) colonization during pregnancy can lead to invasive GBS disease (iGBS) in infants, including meningitis or sepsis, with a high mortality risk. Surviving infants have a higher risk of long-term neurodevelopmental impairment (NDI), especially with meningitis, though it is now understood that NDI after iGBS sepsis has been underestimated and is considered a current data gap. The purpose of this registry is to collect clinical and non-clinical data related to diagnosis and parent reported outcomes of their surviving infants related to long-term NDI.
SIGNIFICANCE Understanding the burden of NDI in this population may help identify opportunities for early screening and intervention for NDI, as interventions are likely to be more effective when offered earlier in life. Additionally, having a better understanding of the impact of iGBS disease on patients and families can help inform needed resources and services.
OBJECTIVES The purpose of the COMPPASS Registry is to establish a comprehensive data repository of patient, patient family, and provider reported outcomes and experiences, that will enhance research on the burden and impact of invasive Group B Streptococcus (iGBS), ultimately informing the development of evidence-based interventions and improving outcomes for at-risk and affected individuals and families.
SPECIFIC AIMS
Specific aims of the registry are to:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A child below the age of 19 who was either diagnosed with or received a lab test result confirming an iGBS infection, or being able to describe their child's condition and experience with iGBS infection at, or within 90 days of, birth.
- •or A child who was diagnosed as having invasive Group B Strep infection within the first 90 days after delivery and later passed away because of the infection or Parent who has experienced a stillbirth due to iGBS infection
- •A sibling(s) from a multi-gestation pregnancy where at least one child was diagnosed as having invasive Group B Strep infection
- •Parent or caregiver who understands and electronically signs the inform consent document
- •In addition to parental or caregiver consent, children between the ages of 13-17 years who are able to understand and provide assent to take part in the study, as confirmed by an electronic signature by their consenting parent or caregiver.
排除标准
- •A child affected by iGBS infection currently over the age of 18.
结局指标
主要结局
Stillbirth Due to Invasive Group B Streptococcus
时间窗: After 20 weeks gestation to the delivery of fetus
Intrauterine fetal death
Parent or Care-giver Reported Diagnosis of Early-Onset Invasive Group B Streptococcus
时间窗: Within 24 Hours of Birth
Parent or Caregiver Reported Diagnosis of Late-Onset Invasive Group B Streptococcus
时间窗: Up to 90 Days after Birth
次要结局
未报告次要终点