SARS CoV 2 InfectionNCT05443607
Transplacental Transmission of RSV (TTRSV)
An observational study of SARS CoV 2 Infection and Respiratory Syncytial Virus (RSV), run by Tulane University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection, Respiratory Syncytial Virus (RSV), Bronchiolitis
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 May 2020to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tulane University Lakeside Hospital
Metairie, Louisiana, 70001
Ochsner Baptist Hospital
New Orleans, Louisiana, 70115
About this study
Official title: A Prospective Cohort Study Evaluating the Transplacental Transmission of Respiratory Syncytial Virus (RSV) in Pregnant Women and Their Offspring
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
Read more
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
Read the detailed description
Patients will be consented at one of two time points during their pregnancy. Option 1: If mothers present or call Obstetrics and Gynecology (OB) with signs or symptoms of an Upper Respiratory Infection (URI) and or a positive SARS-CoV-2 test, the mother's OB will ask if the mother would be interested in hearing about this study at her next prenatal visit if study personnel are not available to discuss the study at the present appointment. If study personnel is available and on-site, they will approach and consent patients who meet criteria after preliminary screening.
Option 2: Mothers who present to labor and delivery and report a history of an URI in the last three weeks and or a history of positive SARS-CoV-2 will be asked by the labor and delivery team or study personnel, if available, about her interest in the study and approached for consent upon admission to labor and delivery. At the time of consent a research blood sample will be drawn if the patient is not already having labs drawn, if the mother agrees.
The additional data collection will be performed electronically. Research staff will contact participants (in person, via email, and via phone, depending on survey timing). REDCap will be used for data collection, with (offline, when necessary) electronic data capture. Participants can access an online version of surveys using their own device or phone, or use tablets provided for the participants for data collection at the hospitals. Participant will have the option to have research staff conduct the question/interview in-person or over the telephone, if this is preferred.
If the mother is enrolled prior to labor, study personnel will then track the enrolled subject's admission to the labor and delivery unit using the electronic health records and regular contact with the OB/GYN service. Study personnel will determine if the subject still meets enrollment criteria after admission to labor and delivery (e.g., baby was carried to at least near full term (34 weeks and beyond) and delivered at either Lakeside Hospital and Clinic or Ochsner Baptist Medical Center). If the patient is still eligible for the study, the study personnel will liaise with bedside nursing to have the maternal research samples collected at the same time standard of care samples are being drawn.
Cord (i.e., fetal) blood, placental tissue, and the newborn naso-pharyngeal aspirate fluid will be collected as early as possible after delivery. All samples will undergo microbiological analyses using Enzyme-Linked Immunoassay (ELISA), Polymerase Chain Reaction (PCR) and CRISPR testing to identify evidence of previous or current infection.
Patients will be given the option of allowing the study team to deidentify and store any remaining maternal and/or infant specimens for additional testing.
Patients will be given the option to allow the study team member to store de-identified remaining maternal and/or infant specimens for future studies.
Patients will be given the option to allow the research team to contact them about their enrollment in any future studies.
All study visits after the collection of biological samples at delivery will be done remotely, through a review of the infant's electronic medical records and questionnaires completed over the phone or via other electronic media (e.g. Zoom) as determined by maternal preference. Mothers will provide information via the use of structured questionnaires delivered and returned by mail every 6 months or by phone based on maternal preference. Telephone interviews and mailed questionnaires will have questions regarding respiratory-related symptoms and diagnoses, allergies, and medications for the index child.
- Keywords
- Fetal blood, COVID-19
- Medical subject headings
- COVID-19, Bronchiolitis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mother infected/newborn not infected | Not described | |
| Mother infected/newborn infected | Not described | |
| Mother not infected/newborn not infected | Not described | |
| Mother not infected/newborn infected | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start25 May 2020
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Giovanni Piedimonte, MD, FAAP, FCCP, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443607
- Sponsor's protocol ID
- 2019-1517
- Status last verified
- May 2026
- First submitted
- 29 Jun 2022
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Evaluating the Transplacental Transmission of Respiratory Syncytial Virus (RSV) in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT05443607
- Acronym / sponsor ID
- 2019-1517
- Keywords
- Fetal blood, COVID-19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 25 May 2020 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 5 Jul 2022 (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.
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
Detailed description
Patients will be consented at one of two time points during their pregnancy. Option 1: If mothers present or call Obstetrics and Gynecology (OB) with signs or symptoms of an Upper Respiratory Infection (URI) and or a positive SARS-CoV-2 test, the mother's OB will ask if the mother would be interested in hearing about this study at her next prenatal visit if study personnel are not available to discuss the study at the present appointment. If study personnel is available and on-site, they will approach and consent patients who meet criteria after preliminary screening.
Option 2: Mothers who present to labor and delivery and report a history of an URI in the last three weeks and or a history of positive SARS-CoV-2 will be asked by the labor and delivery team or study personnel, if available, about her interest in the study and approached for consent upon admission to labor and delivery. At the time of consent a research blood sample will be drawn if the patient is not already having labs drawn, if the mother agrees.
The additional data collection will be performed electronically. Research staff will contact participants (in person, via email, and via phone, depending on survey timing). REDCap will be used for data collection, with (offline, when necessary) electronic data capture. Participants can access an online version of surveys using their own device or phone, or use tablets provided for the participants for data collection at the hospitals. Participant will have the option to have research staff conduct the question/interview in-person or over the telephone, if this is preferred.
If the mother is enrolled prior to labor, study personnel will then track the enrolled subject's admission to the labor and delivery unit using the electronic health records and regular contact with the OB/GYN service. Study personnel will determine if the subject still meets enrollment criteria after admission to labor and delivery (e.g., baby was carried to at least near full term (34 weeks and beyond) and delivered at either Lakeside Hospital and Clinic or Ochsner Baptist Medical Center). If the patient is still eligible for the study, the study personnel will liaise with bedside nursing to have the maternal research samples collected at the same time standard of care samples are being drawn.
Cord (i.e., fetal) blood, placental tissue, and the newborn naso-pharyngeal aspirate fluid will be collected as early as possible after delivery. All samples will undergo microbiological analyses using Enzyme-Linked Immunoassay (ELISA), Polymerase Chain Reaction (PCR) and CRISPR testing to identify evidence of previous or current infection.
Patients will be given the option of allowing the study team to deidentify and store any remaining maternal and/or infant specimens for additional testing.
Patients will be given the option to allow the study team member to store de-identified remaining maternal and/or infant specimens for future studies.
Patients will be given the option to allow the research team to contact them about their enrollment in any future studies.
All study visits after the collection of biological samples at delivery will be done remotely, through a review of the infant's electronic medical records and questionnaires completed over the phone or via other electronic media (e.g. Zoom) as determined by maternal preference. Mothers will provide information via the use of structured questionnaires delivered and returned by mail every 6 months or by phone based on maternal preference. Telephone interviews and mailed questionnaires will have questions regarding respiratory-related symptoms and diagnoses, allergies, and medications for the index child.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mother infected/newborn not infected | – | – |
| Mother infected/newborn infected | – | – |
| Mother not infected/newborn not infected | – | – |
| Mother not infected/newborn infected | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postnatal respiratory morbidity
Time frame: 5 Years
The investigators will monitor the offspring via electronic medical records and mailed questioners to record respiratory symptoms such as upper respiratory infections, cough, wheezing.
Passage of antiviral antibodies from mother to newborn
Time frame: 5 Years
The investigators will assess the antiviral protection provided by maternal fetal transport of neutralizing antibodies following maternal vaccination versus natural infection.
Vertical transmission of RSV and/or SARS-COV2 from infected mother to the offspring
Time frame: 5 Years
The investigators will use PCR to detect the presence of each virus in maternal blood and cord blood.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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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.
Giovanni Piedimonte, MD, FAAP, FCCP principal investigator
Tulane University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection and Respiratory Syncytial Virus (RSV), run by Tulane University at 2 sites in United States.
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 9 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postnatal respiratory morbidity (time frame: 5 Years). The study lists 3 primary outcomes in all. 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 20 May 2026.