Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry
brief summary
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.
detailed description
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:
* Create a cohort of well-characterized patients with perinatal iGBS for participating in retrospective and prospective research * Collect clinical and non-clinical data to support research to understand the range of neurodevelopmental impairment (NDI) associated with iGBS * Collect clinical and non-clinical data to support research to understand the impact of iGBS disease on families of children affected by perinatal iGBS * Collect parent and caregiver-reported patient outcomes following iGBS disease to improve care pathways and support services for affected individuals * Improve awareness of and facilitate enrollment into clinical trials and research studies around perinatal iGBS and NDI
RESEARCH DESIGN AND METHODS The Registry will collect data globally on at least 10,000 children affected by perinatal iGBS over 10 years. It will gather information on the birthing parent's obstetric and pregnancy history, acute illness, postnatal discharge, neurodevelopmental outcomes, and family impact. Participants will consent to share de-identified information relating to these topics and complete validated surveys assessing neurodevelopmental impact at predetermined intervals. To be included in the registry, patients must be ill or had become ill from a group B strep infection at birth through the first 90 days of life and be between the ages of 0 and 19 years of age. In the instance of a multi-gestational pregnancy where at least one child has been diagnosed as having become ill from a Group B Strep infection, the similarly affected and/or unaffected sibling(s) will be invited to take part in the registry. Parents of children who were stillborn due to iGBS infection will also be invited to participate in the registry.