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 range18 Years
SexALL
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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.
✓. 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
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
✕. 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.