Congenital Syphilis Prospective Cohort With Retrospective Evaluation

March 14, 2022 updated by: Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In older children, the sexual route for abuse will be ruled out as a means of interrogation infection and analysis of family dynamics by a multidisciplinary team.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Past 30 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the clinical presentation -symptoms and image findings - in children diagnosed with CS. Symptoms will be measured as present or not and described.
Time Frame: 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.
Past 30 years

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Investigators

  • Principal Investigator: Jaime Altcheh, Dr, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (ACTUAL)

October 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SiC cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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