Early Antibiotic Therapy and Vaccinations in Preterm Infants

Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Vaccination Reaction
• Intervention / Treatment: Drug: ABT

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 Type: Observational
• Enrollment (Anticipated): 82

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • University Hospial Tübingen
      • Contact: Natascha Köstlin-Gille, PD Dr. med.; Phone Number: 0049-7071-2984743; Email: natascha.koestlin@med.uni-tuebingen.de
      • Contact: Laura Haag; Phone Number: 0049-7071-2986268; Email: Laura-alexandra.haag@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants with a gestational age between 24+0 and 31+6 weeks of gestation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ABT in the first week of life; VLBWI with gestational age between 24+0 and 31+6 weeks of gestation with antibiotic treatment in the first week of life	Drug: ABT; any antibiotic therapy in the first week of life; Other Names: any antibiotic therapy
no antibiotic therapy (ABT) in the first week of life; VLBWI with gestational age between 24+0 and 31+6 weeks of gestation without antibiotic treatment in the first week of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Analyses of b- and t-cells development	Analyses of b- and t-cell development with the adjusted age of 4 moth	7 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome analyses	Analyses of the microbiome composition at the age of 14 days and adjusted age of 4 month	7 Month
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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 024/2022BO1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No