Congenital Syphilis Prospective Cohort With Retrospective Evaluation

Congenital Syphilis at Third-level Pediatric Hospital. A Prospective Cohort With Retrospective Evaluation Study of the Last Three Decades.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04137601

Enrollment

Registered

2019-10-24

Start date

2019-07-01

Completion date

2020-03-30

Last updated

2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis, Congenital

Keywords

Congenital syphilis, VDRL, CSF, Clinical manifestations

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 1 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Estimate the most frequent laboratory alterations in patients with CS	Past 30 years	By analizing clinical records we will describe the laboratory findings in both symptomatic and asymptomatic children with CS.

Countries

Argentina

Outcome results