Status:
RECRUITING
Preterm Immune System Development and Response to Immunization
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Medical Center Haaglanden
Amphia Hospital
Conditions:
Immune System Disorder
Preterm
Eligibility:
All Genders
1-2 years
Brief 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.
Detailed Description
Preterm infants are at increased risk of developing infections early in life due to a less mature immune system compared to full-term infants. Moreover, protection by the placental transfer of materna...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT05266664
Start Date
December 8 2022
End Date
July 1 2026
Last Update
March 20 2024
Active Locations (7)
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1
Amphia Hospital
Breda, Netherlands, 4819 EV
2
reinier de Graaff Group
Delft, Netherlands, 2625 AD
3
Albert Schweitzer Hospital
Dordrecht, Netherlands, 3318 AT
4
Erasmus MC
Rotterdam, Netherlands, 3015 GD