Clinical trial NCT04893343: Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
Official title: Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Infection
Keywords: Neonatal infection
Neonatal sepsis
Antibiotic prescribing
Antibiotic stewardship
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 246
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates (aged 0 to 30 days) who are hospitalized for neonatal infection.

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.

Eligibility criteria: Inclusion Criteria:

* Admission to neonatal intensive care unit

Exclusion Criteria:

* None

Primary outcomes:
measure: Antibiotic prescription rate
timeFrame: January 1, 2014 to December 31, 2017
Secondary outcomes:
measure: Antibiotic use compared to other level 2 NICU in same geographic area
timeFrame: January 1, 2014 to December 31, 2017
measure: Antibiotic type
timeFrame: January 1, 2014 to December 31, 2017
measure: Antibiotic treatment duration
timeFrame: January 1, 2014 to December 31, 2017
measure: Clinical and laboratory parameters in neonates with infectious disease diagnosis: Premature rupture of membranes
timeFrame: January 1, 2014 to December 31, 2017
measure: Clinical and laboratory parameters in neonates with infectious disease diagnosis: Mother group B streptococcus positive
timeFrame: January 1, 2014 to December 31, 2017
measure: Clinical and laboratory parameters in neonates with infectious disease diagnosis: Low birthweight
timeFrame: January 1, 2014 to December 31, 2017
measure: Clinical and laboratory parameters in neonates with infectious disease diagnosis: pH umbilical artery at birth
timeFrame: January 1, 2014 to December 31, 2017
measure: Clinical and laboratory parameters in neonates with infectious disease diagnosis: Infant fever on admission
timeFrame: January 1, 2014 to December 31, 2017
measure: Clinical and laboratory parameters in neonates with infectious disease diagnosis: CRP maximum value
timeFrame: January 1, 2014 to December 31, 2017
measure: Clinical and laboratory parameters in neonates with infectious disease diagnosis: Leukocyte count maximum value
timeFrame: January 1, 2014 to December 31, 2017
measure: Use of anthroposophic medications: medication names
timeFrame: January 1, 2014 to December 31, 2017
measure: Use of anthroposophic medications: frequency of use
timeFrame: January 1, 2014 to December 31, 2017
measure: Safety of anthroposophic medications: side effects
timeFrame: January 1, 2014 to December 31, 2017
measure: Safety of anthroposophic medications: adverse drug reactions
timeFrame: January 1, 2014 to December 31, 2017
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Die Filderklinik
state: Baden-Württemberg
Study officials:
affiliation: Arcim Institute
name: Jan Vagedes, Dr
role: PRINCIPAL_INVESTIGATOR
References: