Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
- Conditions
- Neonatal Infection
- Interventions
- Other: No antibiotic treatmentOther: Antibiotic treatment
- Registration Number
- NCT04893343
- Lead Sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Brief 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
- Admission to neonatal intensive care unit
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Neonatal infection without antibiotics No antibiotic treatment In-patient neonates with ICD-10 infectious disease diagnosis, treated without antibiotics Neonatal infection with antibiotics Antibiotic treatment In-patient neonates with ICD-10 infectious disease diagnosis, treated with antibiotics
- Primary Outcome Measures
Name Time Method Antibiotic prescription rate January 1, 2014 to December 31, 2017 Number of antibiotic treatment days per 100 hospital days
- Secondary Outcome Measures
Name Time Method Antibiotic treatment duration January 1, 2014 to December 31, 2017 Mean treatment duration and distribution among recommended therapy durations: 48 hours, 5 days and 7-10 days durations
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Mother group B streptococcus positive January 1, 2014 to December 31, 2017 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
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Low birthweight January 1, 2014 to December 31, 2017 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)
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Infant fever on admission January 1, 2014 to December 31, 2017 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)
Clinical and laboratory parameters in neonates with infectious disease diagnosis: CRP maximum value January 1, 2014 to December 31, 2017 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)
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Premature rupture of membranes January 1, 2014 to December 31, 2017 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
Clinical and laboratory parameters in neonates with infectious disease diagnosis: Leukocyte count maximum value January 1, 2014 to December 31, 2017 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)
Use of anthroposophic medications: frequency of use January 1, 2014 to December 31, 2017 Anthroposophic medications: frequency of use per medication
Safety of anthroposophic medications: adverse drug reactions January 1, 2014 to December 31, 2017 Recording of anthroposophic medication adverse drug reactions (ADR, in grades I-IV, ADR as % of prescriptions)
Antibiotic use compared to other level 2 NICU in same geographic area January 1, 2014 to December 31, 2017 Proportion of neonates having received any antibiotic, compared to proportion in other level 2 NICU in the same geographic area
Clinical and laboratory parameters in neonates with infectious disease diagnosis: pH umbilical artery at birth January 1, 2014 to December 31, 2017 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
Antibiotic type January 1, 2014 to December 31, 2017 Types of antibiotics used, frequency of use per antibiotic type
Use of anthroposophic medications: medication names January 1, 2014 to December 31, 2017 Anthroposophic medications: names of the medications used
Safety of anthroposophic medications: side effects January 1, 2014 to December 31, 2017 Recording of anthroposophic medication side effects
Trial Locations
- Locations (1)
Die Filderklinik
🇩🇪Filderstadt, Baden-Württemberg, Germany