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New study tracks RSV in pregnant women and their babies

NCT ID NCT05443607

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 300 pregnant women who had respiratory infections to see if RSV can pass from mother to baby before birth. Researchers will test blood from mothers and umbilical cords for RSV antibodies and viruses. Babies will be tracked for up to 4 years to monitor respiratory health and growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how RSV is transmitted during pregnancy and inform future prevention strategies for newborns.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

300 people

The number who actually took part.

Started

May 2020

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ochsner Baptist Hospital

    New Orleans, Louisiana, 70115, United States

  • Tulane University Lakeside Hospital

    Metairie, Louisiana, 70001, United States

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