Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry

NCT06896526 | Not Yet Recruiting

• 1 other identifier: CR-2025-IG
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Invasive Group B Streptococcus Disease; Group B Streptococcus; Group B Streptococcal Infection; Group B Streptococcus (GBS) Disease; Group B Streptococcal Infection, Early-Onset; Group B Streptococcal Infection, Late-Onset

Keywords

Invasive Group B Streptococcus Disease; Invasive Group B Streptococcus Registry

Outcome Measures

Primary Outcomes (3)

• Stillbirth Due to Invasive Group B Streptococcus

  Intrauterine fetal death

  After 20 weeks gestation to the delivery of fetus

• Parent or Care-giver Reported Diagnosis of Early-Onset Invasive Group B Streptococcus

  Within 24 Hours of Birth

• Parent or Caregiver Reported Diagnosis of Late-Onset Invasive Group B Streptococcus

  Up to 90 Days after Birth

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• \. A child affected by iGBS infection currently over the age of 18.

Sponsors & Collaborators

• Precia Group: lead

MeSH Terms

Conditions

Streptococcal Infections; Guillain-Barre Syndrome; Disease

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donna Russell, MPA

  Precia Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna Russell, MPA

CONTACT

12069922825; donna.russell@preciagroup.com

Samantha Udondem, MPH

CONTACT

9403431959; samantha.udondem@preciagroup.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 18 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2035
• Study Completion (Estimated): March 31, 2035
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 1 year after publication date
• Access Criteria: Access to de-identified registry data may be granted upon request to the Scientific Advisory Board and the Registry Data Access Committee.