Early Antibiotic Therapy and Vaccinations in Preterm Infants

Recruiting

• Conditions: Vaccination Reaction
• Interventions: Drug: ABT

• Registration Number: NCT05563753
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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

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 31+6 weeks of gestation with antibiotic treatment in the first week of life

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Analyses of SCFA production of the intestinal microbiome	7 month	Analyses of SCFA production of the intestinal microbiome with the age of corrected 4 month
Microbiome analyses	7 Month	Analyses of the microbiome composition at the age of 14 days and adjusted age of 4 month

Trial Locations

Locations (1)

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