NCT05563753

Early Antibiotic Therapy and Vaccinations in Preterm Infants

Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 82 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 24 Weeks – 32 Weeks
• Healthy volunteers: —

Summary

Since the neonatal sepsis is still one of the most common causes of death in preterm infants up to 80% receive an perinatal antibiotic treatment. It is also known that an antibiotic treatment is one of the most important influences for the establishment of the intestinal microbiome. This again is important for the development of an healthy neonatal immunosystem. A pilot study showed that an antibiotic therapy in the first week of life had a negative influence on the vaccine titers of preterm infants. In this study it will be further investigated if an early antibiotic treatment influences the development of the adaptive immunosystem in preterm infants and if this antibiotic treatment effects the development of the intestinal microbiome.

Detailed description

The study wants to investigate the impact of the antibiotic treatment in the first week of live on the adaptive immunosystem. For this the antibody titers against Hepatitis B, Poliomyelitis, Pertussis, Haemophilus influenzae B, Tetanus, Diphtheria and Pneumococcus of very low birth weight infants (VLBWI) who receive an early antibiotic therapy will be compared with the antibody titers of infants who did not receive antibiotic treatment. Further the development of b- and t-cells will be tested. To show the modulation of the intestinal microbiome through antibiotics stool samples of VLBWI with and without antibiotic therapy in first week of life will be tested for their composition and diversity as well as for the production of short-chained fatty acids (SCFA) In this study 82 VLBWI (42 per group) will be included. Infants will be matched by age and gender.

Conditions

• Vaccination Reaction

Interventions

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

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-10-03
• Last updated: 2022-10-12

Locations

1 site across 1 country: Germany