Syphilis, Congenital Clinical Trial
Official title:
Congenital Syphilis at Third-level Pediatric Hospital. A Prospective Cohort With Retrospective Evaluation Study of the Last Three Decades.
| NCT number | NCT04137601 |
| Other study ID # | SiC cohort |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 1, 2019 |
| Est. completion date | March 30, 2020 |
| Verified date | March 2022 |
| Source | Hospital de Niños R. Gutierrez de Buenos Aires |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | March 30, 2020 |
| Est. primary completion date | December 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 1 Year |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires | Buenos Aires |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital de Niños R. Gutierrez de Buenos Aires |
Argentina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Estimate the most frequent laboratory alterations in patients with CS | By analizing clinical records we will describe the laboratory findings in both symptomatic and asymptomatic children with CS. | Past 30 years | |
| Primary | 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 | Describe the clinical presentation -symptoms and image findings - in children diagnosed with CS. Symptoms will be measured as present or not and described. | 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 |