Viewing Study NCT04734782



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Last Modification Date: 2024-10-26 @ 1:55 PM
Study NCT ID: NCT04734782
Status: UNKNOWN
Last Update Posted: 2021-02-02
First Post: 2021-01-28

Brief 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
Sponsor: Hospital Angeles Lomas
Organization: Hospital Angeles Lomas

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2021-01
Last Known Status: ENROLLING_BY_INVITATION
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VSRyCC
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 childrens 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 198620179-87 doi101002jmv1890200110
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 20091542296-298 doi101016jjpeds200807053
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 httpsdoiorg101016jeimc201807002
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None