Early Antibiotic Therapy and Vaccinations in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

Conditions
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Vaccination Reaction

Intervention / Treatment
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* Drug: ABT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: born at University Hospital Tübingen received at least one dose of antibiotics during the first week of life Exclusion Criteria: genetic disorders chronic infections hematological disorders treatment with immunoglobulins during the first 60 days of life immunological disorders infants with Hepatitis B positive mothers

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ABT in the first week of life<br>VLBWI with gestational age between 24+0 and 31+6 weeks of gestation with antibiotic treatment in the first week of life | Drug: ABT<br>* any antibiotic therapy in the first week of life<br>* Other names: any antibiotic therapy;|
| no antibiotic therapy (ABT) in the first week of life<br>VLBWI with gestational age between 24+0 and 31+6 weeks of gestation without antibiotic treatment in the first week of life | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccination response | Measurement of antibody titers against Hepatitis B, Poliomyelitis, Pertussis, Haemophilus Influenzae B, Tetanus, Diphteria and Pneumococcus four month after the first received vaccination | 7 Month | 
| Analyses of b- and t-cells development | Analyses of b- and t-cell development with the adjusted age of 4 moth | 7 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome analyses | Analyses of the microbiome composition at the age of 14 days and adjusted age of 4 month | 7 Month | 
| Analyses of SCFA production of the intestinal microbiome | Analyses of SCFA production of the intestinal microbiome with the age of corrected 4 month | 7 month |