Early Antibiotic Therapy and Vaccination
Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
1 other identifier
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2019
CompletedStudy Start
First participant enrolled
September 27, 2019
CompletedFirst Posted
Study publicly available on registry
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedSeptember 30, 2019
September 1, 2019
2 years
September 27, 2019
September 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
vaccination reaction
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 Outcomes (1)
Microbiome composition
7 months
Study Arms (2)
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
Interventions
any antibiotic therapy in the first week of life
Eligibility Criteria
preterm infants with gestational age between 24+0 and 28+6 weeks of gestation
You may qualify if:
- born at University Hospital Tübingen
- at least one dose of antibiotics within the first week of life
You may not qualify if:
- genetic disorders
- chronic infections
- hematological disorders
- immunoglobulins within the first 60 days of life
- immunological disorders
- infants from Hepatitis B positive mothers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Tübingen, Baden-Wurttemberg, 72076, Germany
Biospecimen
stool samples for microbiome analyses
Study Officials
- PRINCIPAL INVESTIGATOR
Natascha Köstlin-Gille, Dr. med.
Department for Neonatology at University Hospital Tübingen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Junior Research Group Leader
Study Record Dates
First Submitted
September 27, 2019
First Posted
September 30, 2019
Study Start
September 27, 2019
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
September 30, 2019
Record last verified: 2019-09