Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine

Neonatal Infection Clinical Trial

Official title:

Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893343
• Other study ID #: NEO_01
• Status: Completed
• Start date: June 15, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2021
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• Admission to neonatal intensive care unit

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Infections
• Neonatal Infection

Intervention

Other:
• Antibiotic treatment
Antibiotic treatment
• No antibiotic treatment
No antibiotic treatment

Locations

Country	Name	City	State
Germany	Die Filderklinik	Filderstadt	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic prescription rate	Number of antibiotic treatment days per 100 hospital days	January 1, 2014 to December 31, 2017
Secondary	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	January 1, 2014 to December 31, 2017
Secondary	Antibiotic type	Types of antibiotics used, frequency of use per antibiotic type	January 1, 2014 to December 31, 2017
Secondary	Antibiotic treatment duration	Mean treatment duration and distribution among recommended therapy durations: 48 hours, 5 days and 7-10 days durations	January 1, 2014 to December 31, 2017
Secondary	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	January 1, 2014 to December 31, 2017
Secondary	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	January 1, 2014 to December 31, 2017
Secondary	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)	January 1, 2014 to December 31, 2017
Secondary	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	January 1, 2014 to December 31, 2017
Secondary	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)	January 1, 2014 to December 31, 2017
Secondary	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)	January 1, 2014 to December 31, 2017
Secondary	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)	January 1, 2014 to December 31, 2017
Secondary	Use of anthroposophic medications: medication names	Anthroposophic medications: names of the medications used	January 1, 2014 to December 31, 2017
Secondary	Use of anthroposophic medications: frequency of use	Anthroposophic medications: frequency of use per medication	January 1, 2014 to December 31, 2017
Secondary	Safety of anthroposophic medications: side effects	Recording of anthroposophic medication side effects	January 1, 2014 to December 31, 2017
Secondary	Safety of anthroposophic medications: adverse drug reactions	Recording of anthroposophic medication adverse drug reactions (ADR, in grades I-IV, ADR as % of prescriptions)	January 1, 2014 to December 31, 2017