Die Filderklinik
Filderstadt, Baden-Wurttemberg, 70794, Germany
Completed
NCT Number: NCT04893343
Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
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.
Completed
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Notify MeKey information
Conditions
Age range
0 day–30 day
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Admission to neonatal intensive care unit
Exclusion criteria
- None
Treatment and study plan
antibiotic treatment
OtherAntibiotic treatment
No antibiotic treatment
OtherNo antibiotic treatment
Primary outcomes
-
Antibiotic prescription rate
Time frame: January 1, 2014 to December 31, 2017
Number of antibiotic treatment days per 100 hospital days
Secondary outcomes
-
Antibiotic use compared to other level 2 NICU in same geographic area
Time frame: 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
Time frame: January 1, 2014 to December 31, 2017
Types of antibiotics used, frequency of use per antibiotic type
-
Antibiotic treatment duration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: pH umbilical artery at birth
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: January 1, 2014 to December 31, 2017
Anthroposophic medications: names of the medications used
-
Use of anthroposophic medications: frequency of use
Time frame: January 1, 2014 to December 31, 2017
Anthroposophic medications: frequency of use per medication
-
Safety of anthroposophic medications: side effects
Time frame: January 1, 2014 to December 31, 2017
Recording of anthroposophic medication side effects
-
Safety of anthroposophic medications: adverse drug reactions
Time frame: January 1, 2014 to December 31, 2017
Recording of anthroposophic medication adverse drug reactions (ADR, in grades I-IV, ADR as % of prescriptions)
Sponsors and collaborators
Lead sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Other
Registry information
Important dates
- Study start
- 2021
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- May 19, 2021
- Registry last updated
- Jan 4, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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