Transplacental Transmission of RSV (TTRSV) (NCT05443607) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Transplacental Transmission of RSV (TTRSV)
United States300 participantsStarted 2020-05-25
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postnatal respiratory morbidity
Timeframe: 5 Years
2
Passage of antiviral antibodies from mother to newborn
Timeframe: 5 Years
3
Vertical transmission of RSV and/or SARS-COV2 from infected mother to the offspring
. 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.
Exclusion criteria
. 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.