Neonatal InfectionNCT04893343
Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
An observational study of Neonatal Infection, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
The goal of this study is to describe the antibiotic use in a neonatal intensive care unit (NICU) in Germany that is practising integrative medicine. The investigators will review hospital records to find out how often and how long antibiotics were given to newborns; compare antibiotic use to other NICU in the same… Read more about this study
- Who is it for?
- Ages 0 to 30 days
- Conditions the study is for
- Neonatal Infection
- What is being tested?
- Antibiotic treatment and No antibiotic treatment
- How many people
- 246 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2021to 30 Dec 2021
- 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 0 to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates (aged 0 to 30 days) who are hospitalized for neonatal infection.
Who may be able to join
- Admission to neonatal intensive care unit
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to describe the antibiotic use in a neonatal intensive care unit (NICU) in Germany that is practising integrative medicine. The investigators will review hospital records to find out how often and how long antibiotics were given to newborns; compare antibiotic use to other NICU in the same area; describe how sick infected newborns were (comparing those treated with or without antibiotics); and describe which anthroposophic medicines were used, how often and if there were safety problems.
Read the detailed description
A retrospective study, analysing antibiotic use in a level 2 neonatology intensive care unit (NICU) in Germany over a 4-year period from 2014 to 2017. The study will analyse frequency of antibiotic prescribing; compare antibiotic use to other level 2 NICU; compare clinical and laboratory parameters among neonates with infectious disease diagnosis managed with or without antibiotics; use and tolerability of anthroposophic medicinal products.
- Conditions
- Neonatal Infection
- Being tested
- Antibiotic treatment, No antibiotic treatment
- Keywords
- Neonatal infection, Neonatal sepsis, Antibiotic prescribing, Antibiotic stewardship
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic treatmentOther
Antibiotic treatment
No antibiotic treatmentOther
No antibiotic treatment
| Study group | Role | What they receive |
|---|---|---|
| Neonatal infection with antibiotics | In-patient neonates with ICD-10 infectious disease diagnosis, treated with antibiotics Receives: Other: Antibiotic treatment | |
| Neonatal infection without antibiotics | In-patient neonates with ICD-10 infectious disease diagnosis, treated without antibiotics Receives: Other: No antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescription rate
Number of antibiotic treatment days per 100 hospital days
Measured: January 1, 2014 to December 31, 2017
Secondary outcomes (14)
Antibiotic use compared to other level 2 NICU in same geographic area
Proportion of neonates having received any antibiotic, compared to proportion in other level 2 NICU in the same geographic area
Measured: January 1, 2014 to December 31, 2017
Antibiotic type
Types of antibiotics used, frequency of use per antibiotic type
Measured: January 1, 2014 to December 31, 2017
Antibiotic treatment duration
Mean treatment duration and distribution among recommended therapy durations: 48 hours, 5 days and 7-10 days durations
Measured: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Premature rupture of membranes
Descriptive analysis of clinical and laboratory parameters in neonates with ICD-10 infectious disease diagnosis, treated with and without antibiotics. Here: Premature rupture of membranes >24h before birth
Measured: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Mother group B streptococcus positive
Descriptive analysis of clinical and laboratory parameters in neonates with ICD-10 infectious disease diagnosis, treated with and without antibiotics. Here: Mother tested positive for group B streptococcus
Measured: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Low birthweight
Descriptive analysis of clinical and laboratory parameters in neonates with ICD-10 infectious disease diagnosis, treated with and without antibiotics. Here: Neonates with low birthweight (< 2500 g)
Measured: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: pH umbilical artery at birth
Descriptive analysis of clinical and laboratory parameters in neonates with ICD-10 infectious disease diagnosis, treated with and without antibiotics. Here: pH of umbilical artery blood at birth
Measured: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Infant fever on admission
Descriptive analysis of clinical and laboratory parameters in neonates with ICD-10 infectious disease diagnosis, treated with and without antibiotics. Here: Infant fever on admission (≥ 38.0° C)
Measured: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: CRP maximum value
Descriptive analysis of clinical and laboratory parameters in neonates with ICD-10 infectious disease diagnosis, treated with and without antibiotics. Here: Maximum value of C-reactive protein (mg/l)
Measured: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Leukocyte count maximum value
Descriptive analysis of clinical and laboratory parameters in neonates with ICD-10 infectious disease diagnosis, treated with and without antibiotics. Here: Maximum value of leukocyte count (cells per liter)
Measured: January 1, 2014 to December 31, 2017
Use of anthroposophic medications: medication names
Anthroposophic medications: names of the medications used
Measured: January 1, 2014 to December 31, 2017
Use of anthroposophic medications: frequency of use
Anthroposophic medications: frequency of use per medication
Measured: January 1, 2014 to December 31, 2017
Safety of anthroposophic medications: side effects
Recording of anthroposophic medication side effects
Measured: January 1, 2014 to December 31, 2017
Safety of anthroposophic medications: adverse drug reactions
Recording of anthroposophic medication adverse drug reactions (ADR, in grades I-IV, ADR as % of prescriptions)
Measured: January 1, 2014 to December 31, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start15 Jun 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr, Principal investigator, Arcim Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893343
- Sponsor's protocol ID
- NEO_01
- Status last verified
- Dec 2021
- First submitted
- 26 Apr 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Publications
Vagedes J, Huber BM, Islam MOA, Vagedes K, Kohl M, Schoen-Angerer TV. Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine-A Retrospective Analysis. J Integr Complement Med. 2024 Apr;30(4):394-402. doi: 10.1089/jicm.2023.0001. Epub 2023 Oct 9.
PubMed 37815790
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
- ClinicalTrials.gov ID
- NCT04893343
- Acronym / sponsor ID
- NEO_01
- Conditions
- Neonatal Infection
- Keywords
- Neonatal infection, Neonatal sepsis, Antibiotic prescribing, Antibiotic stewardship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 May 2021 (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.
The goal of this study is to describe the antibiotic use in a neonatal intensive care unit (NICU) in Germany that is practising integrative medicine. The investigators will review hospital records to find out how often and how long antibiotics were given to newborns; compare antibiotic use to other NICU in the same area; describe how sick infected newborns were (comparing those treated with or without antibiotics); and describe which anthroposophic medicines were used, how often and if there were safety problems.
Detailed description
A retrospective study, analysing antibiotic use in a level 2 neonatology intensive care unit (NICU) in Germany over a 4-year period from 2014 to 2017. The study will analyse frequency of antibiotic prescribing; compare antibiotic use to other level 2 NICU; compare clinical and laboratory parameters among neonates with infectious disease diagnosis managed with or without antibiotics; use and tolerability of anthroposophic medicinal products.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonatal infection with antibiotics | – | Other: Antibiotic treatmentIn-patient neonates with ICD-10 infectious disease diagnosis, treated with antibiotics |
| Neonatal infection without antibiotics | – | Other: No antibiotic treatmentIn-patient neonates with ICD-10 infectious disease diagnosis, treated without antibiotics |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates (aged 0 to 30 days) who are hospitalized for neonatal infection.
Key inclusion criteria (1 listed)
- Admission to neonatal intensive care unit
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Antibiotic treatmentAntibiotic treatment | Other | Neonatal infection with antibiotics |
| No antibiotic treatmentNo antibiotic treatment | Other | Neonatal infection without antibiotics |
Primary outcome
Antibiotic prescription rate
Time frame: January 1, 2014 to December 31, 2017
Number of antibiotic treatment days per 100 hospital days
14 secondary outcomes
Antibiotic use compared to other level 2 NICU in same geographic area
Time frame: January 1, 2014 to December 31, 2017
Antibiotic type
Time frame: January 1, 2014 to December 31, 2017
Antibiotic treatment duration
Time frame: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Premature rupture of membranes
Time frame: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Mother group B streptococcus positive
Time frame: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Low birthweight
Time frame: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: pH umbilical artery at birth
Time frame: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Infant fever on admission
Time frame: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: CRP maximum value
Time frame: January 1, 2014 to December 31, 2017
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Leukocyte count maximum value
Time frame: January 1, 2014 to December 31, 2017
Use of anthroposophic medications: medication names
Time frame: January 1, 2014 to December 31, 2017
Use of anthroposophic medications: frequency of use
Time frame: January 1, 2014 to December 31, 2017
Safety of anthroposophic medications: side effects
Time frame: January 1, 2014 to December 31, 2017
Safety of anthroposophic medications: adverse drug reactions
Time frame: January 1, 2014 to December 31, 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 37815790Vagedes J, Huber BM, Islam MOA, Vagedes K, Kohl M, Schoen-Angerer TV. Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine-A Retrospective Analysis. J Integr Complement Med. 2024 Apr;30(4):394-402. doi: 10.1089/jicm.2023.0001. Epub 2023 Oct 9.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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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.
Jan Vagedes, Dr principal investigator
Arcim Institute
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 Neonatal Infection, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic prescription rate (time frame: January 1, 2014 to December 31, 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893343, which also lists 1 linked publication.
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 4 Jan 2022.