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Clinical Trials/NCT04137601
NCT04137601CompletedNot Applicable

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

Hospital de Niños R. Gutierrez de Buenos Aires1 site in 1 country62 target enrollmentStarted: July 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
62
Locations
1
Primary Endpoint
Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
0 Days to 1 Year (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital

Time Frame: Past 30 years

By examining clinical records we will describe prevalence of congenital syphilis through last 30 years.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Jaime Altcheh

Principal Investigator

Hospital de Niños R. Gutierrez de Buenos Aires

Study Sites (1)

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