Congenital Syphilis Prospective Cohort With Retrospective Evaluation

NCT04137601 | Completed

• 1 other identifier: SiC cohort
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Syphilis, Congenital

Keywords

Congenital syphilis; VDRL; CSF; Clinical manifestations

Outcome Measures

Primary Outcomes (1)

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

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

  Past 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.

  Past 30 years

Other Outcomes (1)

• Estimate the most frequent laboratory alterations in patients with CS

  Past 30 years

Eligibility Criteria

• Age: 0 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead

Study Sites (1)

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

Buenos Aires, 1425, Argentina

Location

MeSH Terms

Conditions

Syphilis, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Jaime Altcheh, Dr

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: March 30, 2020
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

AR (1)