Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine

NCT ID: NCT04893343

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2021-12-30

Brief Summary

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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

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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.

Conditions

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Neonatal Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neonatal infection with antibiotics

In-patient neonates with ICD-10 infectious disease diagnosis, treated with antibiotics

Antibiotic treatment

Intervention Type OTHER

Antibiotic treatment

Neonatal infection without antibiotics

In-patient neonates with ICD-10 infectious disease diagnosis, treated without antibiotics

No antibiotic treatment

Intervention Type OTHER

No antibiotic treatment

Interventions

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Antibiotic treatment

Antibiotic treatment

Intervention Type OTHER

No antibiotic treatment

No antibiotic treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Admission to neonatal intensive care unit

Exclusion Criteria

* None
Minimum Eligible Age

0 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Vagedes, Dr

Role: PRINCIPAL_INVESTIGATOR

Arcim Institute

Locations

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Die Filderklinik

Filderstadt, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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Vagedes J, Huber BM, Islam MOA, Vagedes K, Kohl M, Schoen-Angerer TV. Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine-A Retrospective Analysis. J Integr Complement Med. 2024 Apr;30(4):394-402. doi: 10.1089/jicm.2023.0001. Epub 2023 Oct 9.

Reference Type DERIVED
PMID: 37815790 (View on PubMed)

Other Identifiers

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NEO_01

Identifier Type: -

Identifier Source: org_study_id

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