Early Antibiotic Therapy and Vaccinations in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaccination Reaction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

ABT

Intervention Type DRUG

any antibiotic therapy in the first week of life

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

No interventions assigned to this group

Interventions

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ABT

any antibiotic therapy in the first week of life

Intervention Type DRUG

Other Intervention Names

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any antibiotic therapy

Eligibility Criteria

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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

Minimum Eligible Age

24 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No