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Transplacental Transmission of RSV (TTRSV)

Active Not RecruitingN/A

Sponsor: Tulane University

Conditions: SARS CoV 2 Infection, Respiratory Syncytial Virus (RSV), Bronchiolitis, Asthma

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Aged 18 years or older;
2. 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
3. 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.
4. History negative for Human Immunodeficiency Virus (HIV)
5. No use of immunosuppressive medications/therapies.
6. Singleton gestation;
7. Willing to allow for follow up of the child via their medical record from the time of delivery to 4 years of age.
8. 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.
9. English or Spanish proficiency

Exclusion Criteria:

1. Under 18 years of age at the time of consent.
2. Gestational age less than 12.0 weeks at the time of consent.
3. 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.
4. Positive medical history for HIV.
5. Current use of immunosuppressive therapies/drugs.
6. Newborn has been diagnosed with congenital abnormality or chronic disease at birth.
7. Unwilling or unable to provide written informed consent.
8. Mother was not pregnant during the RSV season or no positive SARS-CoV-2 test during pregnancy.
9. Subject is unwilling to allow for follow up of the child via medical records from the time of delivery to 4 years of age;
10. Multiple birth;
11. 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.

Locations (2)

Metairie, Louisiana, United States
New Orleans, Louisiana, United States