Early Antibiotic Therapy and Vaccination

• Conditions: Vaccination Reaction
• Interventions: Drug: ABT

• Registration Number: NCT04109833
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09-27
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-27
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• born at University Hospital Tübingen
• at least one dose of antibiotics within the first week of life

Exclusion Criteria

• genetic disorders
• chronic infections
• hematological disorders
• immunoglobulins within the first 60 days of life
• immunological disorders
• infants from Hepatitis B positive mothers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ABT in the first week of life	ABT	VLBWI with gestational age between 24+0 and 28+6 weeks of gestation with antibiotic treatment in the first week of life

Primary Outcome Measures

Name	Time	Method
vaccination reaction	7 months	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)

Secondary Outcome Measures

Name	Time	Method
Microbiome composition	7 months	microbiome analyses of stool samples at age 14 days and corrected 4 months

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Tübingen, Baden-Württemberg, Germany