Early Antibiotic Therapy and Vaccinations in Preterm Infants

Vaccination Reaction Clinical Trial

Official title:

Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563753
• Other study ID #: 024/2022BO1
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: September 2022
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Gender: All
• Age group: 24 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Vaccination Reaction

Intervention

Drug:
• ABT
any antibiotic therapy in the first week of life

Locations

Country	Name	City	State
Germany	University Hospial Tübingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Analyses of b- and t-cells development	Analyses of b- and t-cell development with the adjusted age of 4 moth	7 Month
Secondary	Microbiome analyses	Analyses of the microbiome composition at the age of 14 days and adjusted age of 4 month	7 Month
Secondary	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