RecruitingNCT05266664

Preterm Immune System Development and Response to Immunization

Sponsor

Maastricht University Medical Center

Enrollment

145 participants

Start Date

Dec 8, 2022

Study Type

OBSERVATIONAL

Conditions

Immune System Disorder Preterm Vaccination Failure

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.

Eligibility

Min Age: 1 DayMax Age: 2 Months

Inclusion Criteria8

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 Criteria4

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

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