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.

Study Overview

• Status: Completed
• Conditions: Neonatal Infection
• Intervention / Treatment: Other: Antibiotic treatment; Other: No antibiotic treatment

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.

• Study Type: Observational
• Enrollment (Actual): 246

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Die Filderklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates (aged 0 to 30 days) who are hospitalized for neonatal infection.

Description

Inclusion Criteria:

• Admission to neonatal intensive care unit

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neonatal infection with antibiotics; In-patient neonates with ICD-10 infectious disease diagnosis, treated with antibiotics	Other: Antibiotic treatment; Antibiotic treatment
Neonatal infection without antibiotics; In-patient neonates with ICD-10 infectious disease diagnosis, treated without antibiotics	Other: No antibiotic treatment; No antibiotic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic prescription rate	Number of antibiotic treatment days per 100 hospital days	January 1, 2014 to December 31, 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Antibiotic type	Types of antibiotics used, frequency of use per antibiotic type	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	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	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	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)	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	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)	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)	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)	January 1, 2014 to December 31, 2017
Use of anthroposophic medications: medication names	Anthroposophic medications: names of the medications used	January 1, 2014 to December 31, 2017
Use of anthroposophic medications: frequency of use	Anthroposophic medications: frequency of use per medication	January 1, 2014 to December 31, 2017
Safety of anthroposophic medications: side effects	Recording of anthroposophic medication side effects	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)	January 1, 2014 to December 31, 2017

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Neonatal infection; Neonatal sepsis; Antibiotic stewardship; Antibiotic prescribing
• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: NEO_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication
• IPD Sharing Time Frame: The data will be made available upon publication for a duration of three months.
• IPD Sharing Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No