Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine

NCT04893343 | Completed

• 1 other identifier: NEO_01
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Infection

Keywords

Neonatal infection; Neonatal sepsis; Antibiotic prescribing; Antibiotic stewardship

Outcome Measures

Primary Outcomes (1)

• Antibiotic prescription rate

  Number of antibiotic treatment days per 100 hospital days

  January 1, 2014 to December 31, 2017

Secondary Outcomes (14)

• Antibiotic use compared to other level 2 NICU in same geographic area

  January 1, 2014 to December 31, 2017

• Antibiotic type

  January 1, 2014 to December 31, 2017

• Antibiotic treatment duration

  January 1, 2014 to December 31, 2017

• Clinical and laboratory parameters in neonates with infectious disease diagnosis: Premature rupture of membranes

  January 1, 2014 to December 31, 2017

• Clinical and laboratory parameters in neonates with infectious disease diagnosis: Mother group B streptococcus positive

  January 1, 2014 to December 31, 2017

Study Arms (2)

Neonatal infection with antibiotics

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

Other: Antibiotic treatment

Neonatal infection without antibiotics

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

Other: No antibiotic treatment

Interventions

Antibiotic treatment OTHER

Antibiotic treatment

Neonatal infection with antibiotics

No antibiotic treatment OTHER

No antibiotic treatment

Neonatal infection without antibiotics

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Admission to neonatal intensive care unit

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

Die Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Related Publications (1)

• 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.

  PMID: 37815790 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Vagedes, Dr

  Arcim Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 19, 2021
• Study Start: June 15, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be made available upon publication for a duration of three months.
• 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.

Locations

DE (1)