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Early Antibiotic Therapy and Vaccination

NCT ID: NCT04109833

Last Updated: 2019-09-30

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-27

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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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.

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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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

No interventions assigned to this group

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

ABT

Intervention Type DRUG

any antibiotic therapy in the first week of life

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
* 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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

28 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Natascha Köstlin-Gille

Junior Research Group Leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natascha Köstlin-Gille, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department for Neonatology at University Hospital Tübingen

Locations

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University Hospital

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Natascha Köstlin-Gille, Dr. med.

Role: CONTACT

Phone: 0049-7071-2984743

Email: [email protected]

Christian Gille, Dr. med.

Role: CONTACT

Phone: 0049-7071-83972

Email: [email protected]

Facility Contacts

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Natascha Köstlin, Dr. med.

Role: primary

Other Identifiers

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368/2019BO1

Identifier Type: -

Identifier Source: org_study_id