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Assess the Correlation With Severe Respiratory Syncytial Virus Disease in the First 6 Months in Children With Congenital Heart Disease and Maternal Ac-AntiVSR Titers During Pregnancy

NCT04734782 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-02-02

No results posted yet for this study

Summary

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).

1. \- Nandapalan N, Taylor CE, Greenwell J, et al. Seasonal variations in maternal serum and mammary immunity to RS virus. J Med Virol. 1986;20(1):79-87. doi:10.1002/jmv.1890200110
2. \- Stensballe LG, Ravn H, Kristensen K, Meakins T, Aaby P, Simoes EA. Seasonal variation of maternally derived respiratory syncytial virus antibodies and association with infant hospitalizations for respiratory syncytial virus. J Pediatr. 2009;154(2):296-298. doi:10.1016/j.jpeds.2008.07.053
3. \- Ramos-Fernández JM, et al. Does exposure of pregnant women to epidemic respiratory syncytial virus affect the severity of bronchiolitis? Enferm Infec Microbiol Clin. 2017. https://doi.org/10.1016/j.eimc.2018.07.002)

Conditions

  • Respiratory Syncytial Virus, Congenital Heart Disease

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Hospital Angeles Lomas

    lead OTHER

Eligibility

Min Age
1 Month
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04734782 on ClinicalTrials.gov