Early Antibiotic Therapy and Vaccination

September 27, 2019 updated by: Dr. Natascha Köstlin-Gille, University Hospital Tuebingen

Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

Neonatal Sepsis is one of the most common causes of death in preterm infants. Therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. Antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. In this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to compare antibody titers against Hepatitis B, Polio, Pertussis, Haemophilus influenza B, Tetanus, Diphteria and Pneumococcus in very low birth weight infants (VLBWI) infants who received antibiotic therapy in their first week of life and who did not. In this pilot study, 20 VLBWI infants will be included (10 per group). Infants will be matched fo age and gender.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

preterm infants with gestational age between 24+0 and 28+6 weeks of gestation

Description

Inclusion Criteria:

  • born at University Hospital Tübingen
  • at least one dose of antibiotics within the first week of life

Exclusion Criteria:

  • genetic disorders
  • chronic infections
  • hematological disorders
  • immunoglobulins within the first 60 days of life
  • immunological disorders
  • infants from Hepatitis B positive mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no antibiotic therapy (ABT) in the first week of life
VLBWI with gestational age between 24+0 and 28+6 weeks of gestation without antibiotic treatment in the first week of life
ABT in the first week of life
VLBWI with gestational age between 24+0 and 28+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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vaccination reaction
Time Frame: 7 months
measurement of antibody titers for Hepatitis B, Polio, Pertussis, Haemophilus Influenza B, Tetanus, Diphteria and Pneumococcus 4 months after the first vaccination (at an age of 6 months)
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome composition
Time Frame: 7 months
microbiome analyses of stool samples at age 14 days and corrected 4 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Natascha Köstlin-Gille, Dr. med., Department for Neonatology at University Hospital Tübingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 27, 2019

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (ACTUAL)

September 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 368/2019BO1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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