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Early Antibiotic Therapy and Vaccinations in Preterm Infants

U

University Hospital Tuebingen

Status

Enrolling

Conditions

Vaccination Reaction

Treatments

Drug: ABT

Study type

Observational

Funder types

Other

Identifiers

NCT05563753
024/2022BO1

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

24 to 32 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

82 participants in 2 patient groups

ABT in the first week of life
Description:
VLBWI with gestational age between 24+0 and 31+6 weeks of gestation with antibiotic treatment in the first week of life
Treatment:
Drug: ABT
no antibiotic therapy (ABT) in the first week of life
Description:
VLBWI with gestational age between 24+0 and 31+6 weeks of gestation without antibiotic treatment in the first week of life

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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