Preterm Immune System Development and Response to Immunization (NCT05266664) | Clinical Trial Compass
RecruitingNot Applicable
Preterm Immune System Development and Response to Immunization
Netherlands145 participantsStarted 2022-12-08
Plain-language summary
In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.
Who can participate
Age range1 Day – 2 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
To be eligible to participate in this study, a preterm infant must meet all following criteria:
* Preterm infant born at gestational age less than 32 weeks (whose mothers did or did not receive a T dap vaccination during pregnancy)
* Parents/ guardians must have sufficient understanding of the Dutch language
To be eligible to participate in this study, a healthy full-term infant must meet all following criteria:
* healthy full-term infant whose mother received a Tdap vaccination during pregnancy
* Parents/ guardians must have sufficient understanding of the Dutch language
To be eligible to participate in this study, a mother must meet all following criteria:
\- Mother of preterm or health full-term infant who are participating in the study
Exclusion Criteria:
* Parents/guardians of the infant are not able or willing to provide informed consent
* Infant with congenital anomaly which are more likely to cause adverse effects after immunization (for example hemodynamically significant congenital heart defect)
* Infant with a (possible) HIV infection or immunodeficiency
* Maternal use of immunosuppressive drugs during pregnancy
What they're measuring
1
antibody immune response to routine vaccinations in very preterm infants