Preterm Immune System Development and Response to Immunization

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Mar 3, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how the immune system of very preterm infants (those born before 32 weeks of pregnancy) develops and responds to vaccinations compared to healthy full-term infants. Researchers want to understand if preterm infants, who may have different immune responses, are adequately protected by the current vaccination schedule. The study is currently recruiting participants, including preterm infants, healthy full-term infants, and their mothers who can communicate in Dutch.

To join the study, preterm infants must have been born before 32 weeks of pregnancy, while healthy full-term infants must have mothers who received a specific vaccine (Tdap) during pregnancy. Participants can expect to undergo assessments related to their immune responses to vaccines. It's important to note that infants with certain health issues, like congenital anomalies or HIV infections, cannot participate. This study aims to improve our understanding of vaccination effectiveness in vulnerable populations like preterm infants, ultimately helping to enhance their health and well-being.

Gender

ALL

Eligibility criteria

• 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