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))

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)

Study Overview

• Status: Enrolling by invitation
• Conditions: Respiratory Syncytial Virus, Congenital Heart Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Mexico
  • Ciudad de Mexico, Mexico, 03100
    • Centro Médico Nacional 20 de Noviembre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Angeles Lomas

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Infections; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Virus Diseases; Heart Defects, Congenital; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 025.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data are available upon direct request with the principal investigator through official and unofficial communication.
• IPD Sharing Time Frame: 5 years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No