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Passive transplacental immunity against the respiratory syncytial virus (RSV) appears to mediate infant protection during the first 6 months of life (1). Observations of environmental exposure in pregnant women during an RSV epidemic could influence these children's susceptibility to infection by offering levels of antibodies that are transferred to the fetus. However, there is no prospective study in the population at risk such as children with congenital heart disease, as well as the effective levels of anti-RSV immunoglobulin G (IgG) as protective biomarkers for RSV infection after delivery (2)
Justification
The most serious evolution of the clinical disease of acute RSV bronchiolitis in children under 6 months of age is related to lower exposure of the pregnant woman to the RSV epidemic. With maternal immunization through natural exposure, it is logical to relate protection to children for severe RSV disease. However, it is not proven (3).
A prospective cohort study of mothers with a prenatal diagnosis of a fetus with congenital heart disease will be carried out. To whom titers will be measured. Anti-RSV IGG antibodies result from previous exposure.
According to the IGG titers in anti-RSV serum, 2 groups will be formed:
Protective Mothers (high IGG titers) Non-protective mothers (low IGG titers) The products will be followed up for 6 months after birth to correlate the maternal titers of Ac anti-RSV with the presence and severity of respiratory infection by RSV (Bronchiolitis) in this period.
Population and period
Pregnant women evaluated in the National Medical Center 20 de Noviembre, Pediatric Cardiology service for the prenatal diagnosis of congenital heart disease in their fetuses. Newborns with corroborated congenital heart disease with prenatal diagnosis.
Study inclusion period February 1, 2021, to October 30, 2021. Study follow-up period March 1 2021 to December 30 2021.
Sample type: Non-randomized, for convenience, sequential and with an estimated of 30 patients per group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protective Mothers (high IGG titers) | Protected group Newborns with congenital heart disease + high titers of anti-RSV IGG in the mother's serum before birth |
| |
| Non-protective mothers (low IGG titers) | Unprotected group Newborn with congenital heart disease + negative anti-RSV IGG titers in the mother's serum before birth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Determination of antibodies in maternal serum IgG for respiratory syncytial virus | Diagnostic Test | By venipuncture, a blood sample will be taken and the levels of anti-RSV IgG antibodies will be processed in serum by commercial techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of antibodies in maternal serum IgG for respiratory syncytial virus | By venipuncture, a blood sample will be taken and the levels of anti-RSV IgG antibodies will be processed in serum by commercial techniques. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Elimination criteria
1.- Use of palivizumab
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Pregnant women evaluated in the National Medical Center 20 de Noviembre, Pediatric Cardiology service for the prenatal diagnosis of congenital heart disease in their fetuses. Newborns with corroborated congenital heart disease with prenatal diagnosis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Nacional 20 de Noviembre | Mexico City | 03100 | Mexico |
Data are available upon direct request with the principal investigator through official and unofficial communication.
5 years
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 6, 2025 | |
| Reset | Dec 22, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 6, 2025 | Dec 22, 2025 |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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