Early Antibiotic Therapy and Vaccination

University Hospital Tuebingen

Status: Unknown

Conditions: Vaccination Reaction

Treatments: Drug: ABT

Study type: Observational

Funder types: Other

Identifiers

NCT04109833

368/2019BO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 24 to 28 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

no antibiotic therapy (ABT) in the first week of life

Description:

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

Description:

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

Treatment:

Drug: ABT