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 | Unknown

• 1 other identifier: 025.2021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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.

Non-protective mothers (low IGG titers); Protective Mothers (high IGG titers)

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Non-acceptance of informed consent
• \- Premature birth and need for neonatal intensive care for more than 4 weeks.
• \- Newborn with bronchopulmonary dysplasia
• Elimination criteria
• Use of palivizumab

Sponsors & Collaborators

• Hospital Angeles Lomas: lead

Study Sites (1)

Centro Medico Nacional 20 de Noviembre

Mexico City, 03100, Mexico

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Science

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 2, 2021
• Study Start: February 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years

Locations

ME (1)