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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04893343
Other study ID # NEO_01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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