Understanding how initial influenza exposure affects immunity in infants
Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
Children's Hospital Medical Center, Cincinnati · NCT05436184
This study looks at how babies' first experience with the flu, either from a vaccine or getting sick, affects their immune system and future responses to the virus as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05436184 on ClinicalTrials.gov |
What this trial studies
This observational study aims to define the immune responses of infants to their first exposure to influenza, whether through vaccination or infection, and how this influences their immune response to future exposures. Up to 1500 mother-infant pairs will be enrolled starting from the third trimester of pregnancy and followed until the child reaches three to four years of age. The study will document the natural history of influenza infection and immune response over three flu seasons, utilizing both weekly illness surveillance and medical record reviews. The goal is to fill the knowledge gap regarding maternal immunity and its impact on infant health.
Who should consider this trial
Good fit: Ideal candidates include pregnant women who are at least 34 weeks gestation and plan to deliver at a local hospital within the designated study area.
Not a fit: Patients who may not benefit include those with major congenital anomalies or those enrolled in conflicting clinical trials.
Why it matters
Potential benefit: If successful, this study could lead to improved influenza vaccination strategies for infants, enhancing their immunity and reducing illness.
How similar studies have performed: Other studies have shown success in understanding immune responses to infections, but this specific approach focusing on initial influenza exposure in infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mother pregnant and ≥ 34 weeks gestation and ≥ 18 yrs. of age * Plans to deliver at local hospital * Lives within designated home zip codes: * No plans to move outside study area within study timeframe * Cell phone that can be used for text messaging * Singleton live born infant, born ≥ 34 weeks gestational age (GA) Exclusion Criteria: * Fetal or infant death prior to maternal hospital discharge * Mother known to be infected with HIV based on medical records * Major congenital anomalies, prenatally diagnosed or other major disorder or anomaly as determined by the PI * Reported use of heroin, cocaine or methamphetamines during pregnancy * Adoptive infant * Enrolled in any investigational vaccine trial or other interventional randomized, clinical trial involving the mother or infant that the PI's deem to be in conflict with study outcomes
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Mary Staat, MD,MPH — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Nancy Back, RN,MPH
- Email: Nancy.Back@cchmc.org
- Phone: 513-636-2479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Influenza, influenza, birth cohort