NCT04109833

Early Antibiotic Therapy and Vaccination

Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 24 Weeks – 28 Weeks
• Healthy volunteers: Accepted

Summary

Neonatal Sepsis is one of the most common causes of death in preterm infants. Therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. Antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. In this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.

Detailed description

The aim of the study is to compare antibody titers against Hepatitis B, Polio, Pertussis, Haemophilus influenza B, Tetanus, Diphteria and Pneumococcus in very low birth weight infants (VLBWI) infants who received antibiotic therapy in their first week of life and who did not. In this pilot study, 20 VLBWI infants will be included (10 per group). Infants will be matched fo age and gender.

Conditions

• Vaccination Reaction

Interventions

Type	Name	Description
DRUG	ABT	any antibiotic therapy in the first week of life

Timeline

• Start date: 2019-09-27
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2019-09-30
• Last updated: 2019-09-30

Locations

1 site across 1 country: Germany