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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonatal infection with antibiotics | In-patient neonates with ICD-10 infectious disease diagnosis, treated with antibiotics |
| |
| Neonatal infection without antibiotics | In-patient neonates with ICD-10 infectious disease diagnosis, treated without antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic treatment | Other | Antibiotic treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic prescription rate | Number of antibiotic treatment days per 100 hospital days | January 1, 2014 to December 31, 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | January 1, 2014 to December 31, 2017 |
| Antibiotic type |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates (aged 0 to 30 days) who are hospitalized for neonatal infection.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Vagedes, Dr | Arcim Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Die Filderklinik | Filderstadt | Baden-Wurttemberg | 70794 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37815790 | Derived | 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. |
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IPD that underlie results in a publication
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The data will be made available upon publication for a duration of three months.
The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| No antibiotic treatment |
| Other |
No antibiotic treatment |
|
Types of antibiotics used, frequency of use per antibiotic type |
| 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 | 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 | 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 | 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) | 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 | 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) | 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) | 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) | January 1, 2014 to December 31, 2017 |
| Use of anthroposophic medications: medication names | Anthroposophic medications: names of the medications used | January 1, 2014 to December 31, 2017 |
| Use of anthroposophic medications: frequency of use | Anthroposophic medications: frequency of use per medication | January 1, 2014 to December 31, 2017 |
| Safety of anthroposophic medications: side effects | Recording of anthroposophic medication side effects | 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) | January 1, 2014 to December 31, 2017 |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |