Neonatal Infection Clinical Trial
Official title:
Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Die Filderklinik | Filderstadt | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
ARCIM Institute Academic Research in Complementary and Integrative Medicine |
Germany,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04200807 -
Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
|
||
Recruiting |
NCT05695196 -
Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant
|
Phase 1 | |
Completed |
NCT01729000 -
Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis
|
N/A | |
Completed |
NCT06413056 -
Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection
|
Phase 4 | |
Completed |
NCT03247920 -
Reduction of Intravenous Antibiotics In Neonates
|
Phase 4 | |
Completed |
NCT02486783 -
Infection, Sepsis and Meningitis in Surinamese Neonates
|
N/A | |
Recruiting |
NCT06194396 -
Effect of Chlorhexidine Versus Alcohol on Infections in Neonates
|
N/A | |
Active, not recruiting |
NCT05343403 -
Parental Participation on the Neonatal Ward - the neoPARTNER Study
|
||
Recruiting |
NCT04416373 -
COVID-19 and Pregnancy Outcomes
|
||
Completed |
NCT01540162 -
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
|
N/A | |
Withdrawn |
NCT03673566 -
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
|
N/A | |
Completed |
NCT04883801 -
Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19
|
||
Terminated |
NCT05379452 -
Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai
|
||
Active, not recruiting |
NCT04718220 -
Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19
|
N/A | |
Not yet recruiting |
NCT06102044 -
Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
|
Phase 3 | |
Active, not recruiting |
NCT04433364 -
COPE - COVID-19 in Pregnancy and Early Childhood
|
||
Completed |
NCT03383211 -
Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
|
||
Withdrawn |
NCT03673579 -
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
|
N/A | |
Completed |
NCT04206878 -
Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
|
||
Recruiting |
NCT05743816 -
Neonatal Antimicrobial Resistance and Outcome
|