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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no antibiotic therapy (ABT) in the first week of life | VLBWI with gestational age between 24+0 and 28+6 weeks of gestation without antibiotic treatment in the first week of life | ||
| ABT in the first week of life | VLBWI with gestational age between 24+0 and 28+6 weeks of gestation with antibiotic treatment in the first week of life |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT | Drug | any antibiotic therapy in the first week of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| vaccination reaction | measurement of antibody titers for Hepatitis B, Polio, Pertussis, Haemophilus Influenza B, Tetanus, Diphteria and Pneumococcus 4 months after the first vaccination (at an age of 6 months) | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome composition | microbiome analyses of stool samples at age 14 days and corrected 4 months | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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preterm infants with gestational age between 24+0 and 28+6 weeks of gestation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natascha Köstlin-Gille, Dr. med. | Contact | 0049-7071-2984743 | natascha.koestlin@med.uni-tuebingen.de | |
| Christian Gille, Dr. med. | Contact | 0049-7071-83972 | christian.gille@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Natascha Köstlin-Gille, Dr. med. | Department for Neonatology at University Hospital Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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stool samples for microbiome analyses