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OpenTrials
Completed

NCT Number: NCT04137601

Congenital Syphilis Prospective Cohort With Retrospective Evaluation

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.

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Key information

Conditions

Syphilis, Congenital Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infections Spirochaetales Infections Syphilis Treponemal Infections

Age range

0 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Buenos Aires, 1425, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 24, 2019
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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