Status:
NOT_YET_RECRUITING
Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry
Lead Sponsor:
Precia Group
Conditions:
Invasive Group B Streptococcus Disease
Group B Streptococcus
Eligibility:
All Genders
Up to 18 years
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 ...
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. A child affected by iGBS infection currently over the age of 18.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2035
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT06896526
Start Date
April 1 2025
End Date
March 31 2035
Last Update
March 26 2025
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