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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorPrecia Group

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Stillbirth Due to Invasive Group B Streptococcus

Intrauterine fetal death

Time frame
After 20 weeks gestation to the delivery of fetus
2

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

Time frame
Within 24 Hours of Birth
3

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

Time frame
Up to 90 Days after Birth

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: