Congenital Syphilis Prospective Cohort With Retrospective Evaluation

Completed

• Conditions: Syphilis, Congenital

• Registration Number: NCT04137601
• Lead Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Brief Summary

Syphilis is an infectious disease caused by Treponema pallidum. In children, there are two different forms of this disease; acquired syphilis and congenital syphilis, which results from transplacental transmission of spirochetes.

The worldwide incidence of congenital syphilis has increased in past years, probably due to inadequate control of pregnant women and lack of early diagnose and treatment in acute infected adults.

This infection can have numerous and non-specific manifestations at all stages, and may simulate other diseases, which can delay diagnose if not suspected.

A high number of newborns can be asymptomatic, so diagnose is confirmed or discharged by serologic testing after 6 to 10 months of age.

This study will observe the clinical presentation and the laboratory of patients with CS treated.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-24
• Primary Completion: 2019-12-30
• Study Completion: 2020-03-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Infants with reactive VDRL /RPR of mothers with positive serology without confirmed treatment or incomplete.
• Patients with compatible clinical signs of syphils.

Exclusion Criteria

• Patients with diagnosis of acquired syphilis
• Patients whose medical records are missing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital	Past 30 years	By examining clinical records we will describe prevalence of congenital syphilis through last 30 years.

Secondary Outcome Measures

Name	Time	Method
Describe the clinical presentation -symptoms and image findings - in children diagnosed with CS. Symptoms will be measured as present or not and described.	Past 30 years	By looking at clinical records we will describe the number of children presenting with symptoms and number of asymptomatic. We will also describe the most frequent symptoms found and other test findings.

Trial Locations

Locations (1)

Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires; 🇦🇷 Buenos Aires, Argentina