Transplacental Transmission of RSV (TTRSV)

NCT05443607 | Active Not Recruiting

• 1 other identifier: 2019-1517
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Aim 1: To study transplacental transmission of Respiratory Syncytial Virus (RSV) and how this is moderated by other maternal infections during pregnancy Aim 2: To test maternal blood for presence of RSV-specific immunoglobulins and how this is moderated by other maternal infections during pregnancy Aim 3: To test cord blood (fetal blood) for presence of RSV-specific immunoglobulins and other common viral pathogens Aim 4: To perform further tests (Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Droplet Digital Polymerase Chain Reaction (ddPCR) and immunoprobing) to confirm the presence of RSV and other common viral pathogens Aim 5: To follow these newborn infants up to 4 years of age to look for redisposition to respiratory diseases and growth parameters

Conditions

SARS CoV 2 Infection; Respiratory Syncytial Virus (RSV); Bronchiolitis; Asthma

Keywords

Fetal blood; COVID-19

Outcome Measures

Primary Outcomes (3)

• Postnatal respiratory morbidity

  The investigators will monitor the offspring via electronic medical records and mailed questioners to record respiratory symptoms such as upper respiratory infections, cough, wheezing.

  5 Years

• Passage of antiviral antibodies from mother to newborn

  The investigators will assess the antiviral protection provided by maternal fetal transport of neutralizing antibodies following maternal vaccination versus natural infection.

  5 Years

• Vertical transmission of RSV and/or SARS-COV2 from infected mother to the offspring

  The investigators will use PCR to detect the presence of each virus in maternal blood and cord blood.

  5 Years

Study Arms (4)

Mother infected/newborn not infected

Mother infected/newborn infected

Mother not infected/newborn not infected

Mother not infected/newborn infected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women who plan to deliver at Tulane Lakeside Hospital and Clinic and Ochsner Baptist Medical Center will be considered for inclusion in the study. Pregnant women and their infants who fulfill all inclusion criteria are eligible for participation.

You may qualify if:

• Aged 18 years or older;
• Reported 2 or more signs and symptoms of respiratory infection during pregnancy, including but not limited to: fever, nasal congestion/discharge, cough, and sore throat and/or a positive SARS-CoV-2 test
• Deliveries at full term or near term (minimum 34 weeks gestation) in Labor and Delivery (L\&D) facilities at Tulane Lakeside Hospital and Clinic or Ochsner Baptist Medical Center who were pregnant during RSV season.
• History negative for Human Immunodeficiency Virus (HIV)
• No use of immunosuppressive medications/therapies.
• Singleton gestation;
• Willing to allow for follow up of the child via their medical record from the time of delivery to 4 years of age.
• Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
• English or Spanish proficiency

You may not qualify if:

• Under 18 years of age at the time of consent.
• Gestational age less than 12.0 weeks at the time of consent.
• Does not report at least 2 of the following signs and symptoms of respiratory infection during pregnancy, including but not limited to: fever, nasal congestion/discharge, cough, and sore throat.
• Positive medical history for HIV.
• Current use of immunosuppressive therapies/drugs.
• Newborn has been diagnosed with congenital abnormality or chronic disease at birth.
• Unwilling or unable to provide written informed consent.
• Mother was not pregnant during the RSV season or no positive SARS-CoV-2 test during pregnancy.
• Subject is unwilling to allow for follow up of the child via medical records from the time of delivery to 4 years of age;
• Multiple birth;
• Lacks English or Spanish proficiency
• Infants will be excluded from the study in the event of a Serious Adverse Event such as fetal or acute neonatal death (in the delivery room) if the mother does not provide clinical consent for an autopsy.

Sponsors & Collaborators

• Tulane University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Tulane University Lakeside Hospital

Metairie, Louisiana, 70001, United States

Location

Ochsner Baptist Hospital

New Orleans, Louisiana, 70115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

The investigators are extracting RNA for PCR amplification from blood cells, placenta and nasopharyngeal aspirate.

MeSH Terms

Conditions

COVID-19; Bronchiolitis; Asthma

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Giovanni Piedimonte, MD, FAAP, FCCP

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: May 25, 2020
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

US (2)