Respiratory Syncytial Virus, Congenital Heart Disease(VSRyCC)NCT04734782
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
An observational study of Respiratory Syncytial Virus, Congenital Heart Disease, run by Hospital Angeles Lomas at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Respiratory Syncytial Virus, Congenital Heart Disease
- What is being tested?
- Determination of antibodies in maternal serum IgG for respiratory syncytial virus
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 15 Feb 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- - Non-acceptance of informed consent
- - Premature birth and need for neonatal intensive care for more than 4 weeks.
- - Newborn with bronchopulmonary dysplasia
- Elimination criteria
- 1.- Use of palivizumab
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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).
- - 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
- - 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
- - 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)
Read the 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.
- Being tested
- Determination of antibodies in maternal serum IgG for respiratory syncytial virus
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of antibodies in maternal serum IgG for respiratory syncytial virusDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: Determination of antibodies in maternal serum IgG for respiratory syncytial virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start15 Feb 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus, Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Angeles Lomas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humberto Garcia Aguilar, Hospital Angeles Lomas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734782
- Sponsor's protocol ID
- 025.2021
- Acronym
- (VSRyCC)
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon direct request with the principal investigator through official and unofficial communication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04734782
- Acronym / sponsor ID
- (VSRyCC) / 025.2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Angeles LomasUniversity, hospital or other
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- - 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
- - 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
- - 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)
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protective Mothers (high IGG titers) | – | Diagnostic Test: Determination of antibodies in maternal serum IgG for respiratory syncytial virusProtected group Newborns with congenital heart disease + high titers of anti-RSV IGG in the mother's serum before birth |
| Non-protective mothers (low IGG titers) | – | Diagnostic Test: Determination of antibodies in maternal serum IgG for respiratory syncytial virusUnprotected group Newborn with congenital heart disease + negative anti-RSV IGG titers in the mother's serum before birth. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- - Non-acceptance of informed consent
- - Premature birth and need for neonatal intensive care for more than 4 weeks.
- - Newborn with bronchopulmonary dysplasia
- Elimination criteria
- 1.- Use of palivizumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of antibodies in maternal serum IgG for respiratory syncytial virusBy venipuncture, a blood sample will be taken and the levels of anti-RSV IgG antibodies will be processed in serum by commercial techniques. | Diagnostic test | Non-protective mothers (low IGG titers), Protective Mothers (high IGG titers) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Yes. Data are available upon direct request with the principal investigator through official and unofficial communication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus, Congenital Heart Disease, run by Hospital Angeles Lomas at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of antibodies in maternal serum IgG for respiratory syncytial virus (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.