An observational study in Neonatal Infection, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to participants aged 0 Days to 30 Days. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 246 is close to the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →ARCIM Institute Academic Research in Complementary and Integrative Medicine is the lead sponsor of 30 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Neonates (aged 0 to 30 days) who are hospitalized for neonatal infection.
Exclusion Criteria:
In-patient neonates with ICD-10 infectious disease diagnosis, treated with antibiotics
Other: Antibiotic treatment
In-patient neonates with ICD-10 infectious disease diagnosis, treated without antibiotics
Other: No antibiotic treatment
Antibiotic treatment
No antibiotic treatment
Antibiotic prescription rate
Number of antibiotic treatment days per 100 hospital days
Time frame: January 1, 2014 to December 31, 2017
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
Time frame: January 1, 2014 to December 31, 2017
Antibiotic type
Types of antibiotics used, frequency of use per antibiotic type
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: January 1, 2014 to December 31, 2017
Use of anthroposophic medications: medication names
Anthroposophic medications: names of the medications used
Time frame: January 1, 2014 to December 31, 2017
Use of anthroposophic medications: frequency of use
Anthroposophic medications: frequency of use per medication
Time frame: January 1, 2014 to December 31, 2017
Safety of anthroposophic medications: side effects
Recording of anthroposophic medication side effects
Time frame: 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)
Time frame: January 1, 2014 to December 31, 2017
Plan to share: Yes — IPD that underlie results in a publication
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ARCIM Institute Academic Research in Complementary and Integrative Medicine