Neonatal Infection
Conditions
Keywords
Neonatal infection, Neonatal sepsis, Antibiotic prescribing, Antibiotic stewardship
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.
Interventions
OTHERAntibiotic treatment
Antibiotic treatment
No antibiotic treatment
Sponsors
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 30 Days
Healthy volunteers
No
Inclusion criteria
* Admission to neonatal intensive care unit
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic prescription rate | January 1, 2014 to December 31, 2017 | Number of antibiotic treatment days per 100 hospital days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Antibiotic type | January 1, 2014 to December 31, 2017 | Types of antibiotics used, frequency of use per antibiotic type |
| 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: 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: 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 |
| Safety of anthroposophic medications: side effects | January 1, 2014 to December 31, 2017 | Recording of anthroposophic medication side effects |
| 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 |
| 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: 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: medication names | January 1, 2014 to December 31, 2017 | Anthroposophic medications: names of the medications used |
| Use of anthroposophic medications: frequency of use | January 1, 2014 to December 31, 2017 | Anthroposophic medications: frequency of use per medication |
| 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) |
Countries
Germany
Outcome results
None listed