UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051989 |
|---|---|
| Receipt number | R000059333 |
| Scientific Title | Appropriate use of antibiotics using a serum procalcitonin 95%ile cutoff value for neonatal early-onset bacterial infections |
| Date of disclosure of the study information | 2023/08/24 |
| Last modified on | 2023/08/24 08:33:58 |
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Basic information
Public title
Appropriate use of antibiotics using a serum procalcitonin 95%ile cutoff value for neonatal early-onset bacterial infections
Acronym
Appropriate use of antibiotics using a serum procalcitonin 95%ile cutoff value for neonatal early-onset bacterial infections
Scientific Title
Appropriate use of antibiotics using a serum procalcitonin 95%ile cutoff value for neonatal early-onset bacterial infections
Scientific Title:Acronym
Appropriate use of antibiotics using a serum procalcitonin 95%ile cutoff value for neonatal early-onset bacterial infections
Region
| Japan |
Condition
Condition
Neonatal early-onset bacterial infection
Classification by specialty
| Pediatrics | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We previously reported the 95%ile cutoff value of the serum procalcitonin (PCT) reference curve for preterm neonates and the combination of the 95%ile cutoff value of the serum PCT reference curve, C-reactive protein, white blood cell count, and IgM for term neonates in diagnosing early-onset bacterial infection (Diagnostics, 2020). This study aimed to verify the usefulness of this novel diagnostic criteria by comparing the use of antibiotics and the incidence of early-onset bacterial infection between pre- and post-introduction periods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Days of antibiotics therapy (DOT) per 1,000 patient-days up to 6 days after birth, newborn number (%) of usage antibiotics, and the incidence of early-onset bacterial infections
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
We included newborns admitted to our NICU who underwent blood tests within 72 hours after birth between 2018, and 2022. They were divided into the pre-intervention (those who admitted before the introduction, n=737) or intervention (those who admitted after the introduction, n=686) groups
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 7 | days-old | > |
Gender
Male and Female
Key inclusion criteria
We included newborns admitted to our NICU who underwent blood tests within 72 hours after birth between 2018, and 2022. They were divided into the pre-intervention (those who admitted before the introduction, n=737) or intervention (those who admitted after the introduction, n=686) groups
Key exclusion criteria
Death within 6 days after birth
Target sample size
1350
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Nagano |
Organization
Nihon University School of Medicine
Division name
Department of Pediatrics and Child Health
Zip code
173-8610
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
+81-3-3972-8111
nagano.nobuhiko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Nagano |
Organization
Nihon University School of Medicine
Division name
Department of Pediatrics and Child Health
Zip code
173-8610
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
+81-3-3972-8111
Homepage URL
nagano.nobuhiko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
Tel
+81-3-3972-8111
nagano.nobuhiko@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1429
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059333
