About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
None
Trial population
Child(ren) who are ill or had become ill from a Group B Streptococcus 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. Information from parents of children who were stillborn will also be collected.
Trial design
Other
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Stillbirth Due to Invasive Group B Streptococcus
Intrauterine fetal death
Parent or Care-giver Reported Diagnosis of Early-Onset Invasive Group B Streptococcus
Parent or Caregiver Reported Diagnosis of Late-Onset Invasive Group B Streptococcus
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: