Early Antibiotic Therapy and Vaccinations in Preterm Infants
Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
1 other identifier
observational
82
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
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
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 28, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedOctober 12, 2022
September 1, 2022
2 years
September 28, 2022
October 7, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Vaccination response
Measurement of antibody titers against Hepatitis B, Poliomyelitis, Pertussis, Haemophilus Influenzae B, Tetanus, Diphteria and Pneumococcus four month after the first received vaccination
7 Month
Analyses of b- and t-cells development
Analyses of b- and t-cell development with the adjusted age of 4 moth
7 Month
Secondary Outcomes (2)
Microbiome analyses
7 Month
Analyses of SCFA production of the intestinal microbiome
7 month
Study Arms (2)
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
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
Interventions
any antibiotic therapy in the first week of life
Eligibility Criteria
Preterm infants with a gestational age between 24+0 and 31+6 weeks of gestation
You may qualify if:
- born at University Hospital Tübingen
- received at least one dose of antibiotics during the first week of life
You may not qualify if:
- genetic disorders
- chronic infections
- hematological disorders
- treatment with immunoglobulins during the first 60 days of life
- immunological disorders
- infants with Hepatitis B positive mothers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospial Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Biospecimen
stool samples for microbiome analyses blood for vaccination titers and b- and t-cell analyses
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2022
First Posted
October 3, 2022
Study Start
September 1, 2022
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
October 12, 2022
Record last verified: 2022-09