Vaccination ReactionNCT05563753
Early Antibiotic Therapy and Vaccinations in Preterm Infants
An observational study of Vaccination Reaction, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Vaccination Reaction
- What is being tested?
- ABT
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2022to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- Child
Study population: Preterm infants with a gestational age between 24+0 and 31+6 weeks of gestation
Who may be able to join
- born at University Hospital Tübingen
- received at least one dose of antibiotics during the first week of life
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospial Tübingen
Tübingen, Baden-Wurttemberg, 72076
Natascha Köstlin-Gille, PD Dr. med., 0049-7071-2984743, natascha.koestlin@med.uni-tuebingen.de
Laura Haag, 0049-7071-2986268, Laura-alexandra.haag@med.uni-tuebingen.de
About this study
Official title: Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
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.
Read the detailed 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.
- Conditions
- Vaccination Reaction
- Being tested
- ABT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABTDrug
Also called any antibiotic therapy
any antibiotic therapy in the first week of life
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ABT | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 Month
Analyses of b- and t-cells development
Analyses of b- and t-cell development with the adjusted age of 4 moth
Measured: 7 Month
Secondary outcomes (2)
Microbiome analyses
Analyses of the microbiome composition at the age of 14 days and adjusted age of 4 month
Measured: 7 Month
Analyses of SCFA production of the intestinal microbiome
Analyses of SCFA production of the intestinal microbiome with the age of corrected 4 month
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Sep 2022
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination ReactionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563753
- Sponsor's protocol ID
- 024/2022BO1
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
- ClinicalTrials.gov ID
- NCT05563753
- Acronym / sponsor ID
- 024/2022BO1
- Conditions
- Vaccination Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT in the first week of life | – | Drug: ABTVLBWI 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 |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Preterm infants with a gestational age between 24+0 and 31+6 weeks of gestation
Key inclusion criteria (2 listed)
- born at University Hospital Tübingen
- received at least one dose of antibiotics during the first week of life
Key exclusion criteria (6 listed)
- genetic disorders
- chronic infections
- hematological disorders
- treatment with immunoglobulins during the first 60 days of life
- immunological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABTAlso: any antibiotic therapyany antibiotic therapy in the first week of life | Drug | ABT in the first week of life |
Primary outcome
Vaccination response
Time frame: 7 Month
Measurement of antibody titers against Hepatitis B, Poliomyelitis, Pertussis, Haemophilus Influenzae B, Tetanus, Diphteria and Pneumococcus four month after the first received vaccination
Analyses of b- and t-cells development
Time frame: 7 Month
Analyses of b- and t-cell development with the adjusted age of 4 moth
2 secondary outcomes
Microbiome analyses
Time frame: 7 Month
Analyses of SCFA production of the intestinal microbiome
Time frame: 7 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination Reaction, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination response (time frame: 7 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.