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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 ((VSRyCC))

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ClinicalTrials.gov Identifier: NCT04734782
Recruitment Status : Enrolling by invitation
First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Humberto Garcia Aguilar, Hospital Angeles Lomas

Study Description
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Brief 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)

Condition or disease Intervention/treatment
Respiratory Syncytial Virus, Congenital Heart Disease Diagnostic Test: Determination of antibodies in maternal serum IgG for respiratory syncytial virus

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Determination of antibodies in maternal serum IgG for respiratory syncytial virus [ Time Frame: 12 months ]
    By venipuncture, a blood sample will be taken and the levels of anti-RSV IgG antibodies will be processed in serum by commercial techniques.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Pregnant mothers in the third trimester of gestational age, with a child with congenital heart disease diagnosed by fetal echocardiogram
  2. Approval of informed consent
  3. Newborn of term or preterm, with corroborated congenital heart disease and presenting with a respiratory infection by RSV

Exclusion Criteria:

  1. - Non-acceptance of informed consent
  2. - Premature birth and need for neonatal intensive care for more than 4 weeks.
  3. - Newborn with bronchopulmonary dysplasia

Elimination criteria

1.- Use of palivizumab

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734782


Locations
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Mexico
Centro Medico Nacional 20 de Noviembre
Ciudad de Mexico, Mexico, 03100
Sponsors and Collaborators
Hospital Angeles Lomas
More Information
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Responsible Party: Humberto Garcia Aguilar, Master in Science, Hospital Angeles Lomas
ClinicalTrials.gov Identifier: NCT04734782    
Other Study ID Numbers: 025.2021
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are available upon direct request with the principal investigator through official and unofficial communication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 5 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Heart Diseases
Heart Defects, Congenital
Infections
Cardiovascular Diseases
 Cardiovascular Abnormalities
Congenital Abnormalities
Antibodies
Immunologic Factors
Physiological Effects of Drugs