Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine

Conditions
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Neonatal Infection

Intervention / Treatment
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* Other: Antibiotic treatment
* Other: No antibiotic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to neonatal intensive care unit Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonatal infection with antibiotics<br>In-patient neonates with ICD-10 infectious disease diagnosis, treated with antibiotics | Other: Antibiotic treatment<br>* Antibiotic treatment<br>|
| Neonatal infection without antibiotics<br>In-patient neonates with ICD-10 infectious disease diagnosis, treated without antibiotics | Other: No antibiotic treatment<br>* No antibiotic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic prescription rate | Number of antibiotic treatment days per 100 hospital days | January 1, 2014 to December 31, 2017 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal infection, Neonatal sepsis, Antibiotic prescribing, Antibiotic stewardship