UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050532 |
|---|---|
| Receipt number | R000057548 |
| Scientific Title | The effectiveness and safety of implementation of a multi-disciplinary antimicrobial stewardship program in very preterm infants immediately after birth: a multicenter observational study in Japan |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2025/03/10 12:33:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Antimicrobial stewardship program in very preterm infants
Acronym
EOS study
Scientific Title
The effectiveness and safety of implementation of a multi-disciplinary antimicrobial stewardship program in very preterm infants immediately after birth: a multicenter observational study in Japan
Scientific Title:Acronym
EOS study
Region
| Japan |
Condition
Condition
Very preterm infant
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the effectiveness and safety of implementation of a multi-disciplinary antimicrobial stewardship program in very preterm infants immediately after birth in Japanese multicenter NICU.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy: Days of antibiotics use beyond postnatal day7
Safety: Death during NICU stay
Key secondary outcomes
1.Early onset neonatal sepsis
2. Late onset neonatal sepsis NICU
3. Death during NICU stay/Late onset neonatal sepsis
4. Antibiotic consumption in NICU ward
5. The rate of proper antibiotic use beyond postnatal day 3
6. Prolonged antibiotic use (over 5 days without positive blood culture)
7. Resumption of antibiotics within 5 days after discontinuation of antibiotics
8. Acquisition of multidrug resistant organisms during NICU stay
9. Severe intraventricular hemorrhage/Necrotizing enterocolitis/focal intestinal perforation/chronic lung disease at 36 weeks postconceptional age
10. The period of NICU stay
11. The rate of EOS checklist use
12. Create team for antimicrobial steward ship in NICU
13. Create corporation with microbiological laboratory
14. Sharing the feedback information about institutional antibiotic consumption
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Infants with a birth weight of less than 1500 grams or infants with a gestational age of less than 32 weeks
2. Infants who admitted within postnatal day 3
Key exclusion criteria
1. Infant who admitted beyond postnatal day 3
2. Infant withhold resuscitation attempt because of lethal disease or death in delivery room
Target sample size
564
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Matsunaga |
Organization
National Center for Global Health and Medicine Hospital
Division name
AMR Clinical Reference Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, JAPNA
TEL
+81-3-6228-0062
nomatsunaga@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kinoshita |
Organization
Japanese Red Cross Kyoto Daiichi Hospital
Division name
Division of Neonatology
Zip code
605-0981
Address
15-749 Honmachi, Higashiyama-ku, Kyoto, JAPAN
TEL
+81-75-561-1121
Homepage URL
https://eos.ncgm.go.jp/
daisuke-kinoshita@kyoto1.jrc.or.jp
Sponsor or person
Institute
National Center for Global Health and Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health research foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
1. Japanese Red Cross Kyoto Daiichi Hospital
2. Tokyo Metropolitan Children's Medical Center
3. Osaka Women's and Children's Hospital
4. Niigata University Medical & Dental Hospital
5. University Hospital Kyoto prefectural University of Medicine
Name of secondary funder(s)
Japan Society of Perinatal and Neonatal Medicine
IRB Contact (For public release)
Organization
Institutional Review Board of National Center for Global Health and Medicine
Address
1-21-1 Toyama, shinzyuku,Tokyo 162-8655, Japan
Tel
+81-3-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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
京都第一赤十字病院（京都府）
地方独立行政法人東京都立病院機構東京都立小児総合医療センター（東京都）
地方独立行政法人大阪府立病院機構大阪母子医療センター（大阪府）
新潟大学医歯学総合病院（新潟県）
京都府立医科大学附属病院（京都府）
岩手医科大学附属病院（岩手県）
群馬県立小児医療センター（群馬県）
桐生厚生総合病院（群馬県）
国立大学法人群馬大学医学部附属病院（群馬県）
日本赤十字社 成田赤十字病院（千葉県）
国立大学法人 千葉大学医学部附属病院（千葉県）
社会福祉法人恩賜財団 母子愛育会 総合母子保健センター愛育病院（東京都）
国立研究開発法人 国立成育医療研究センター（東京都）
東京女子医科大学病院（東京都）
日本赤十字社医療センター（東京都）
地方独立行政法人東京都立病院機構東京都立墨東病院（東京都）
東邦大学医療センター大森病院（東京都）
東京慈恵会医科大学附属病院（東京都）
昭和大学横浜市北部病院（神奈川県）
長岡赤十字病院（新潟県）
新潟市民病院（新潟県）
国立大学法人富山大学附属病院（富山県）
石川県立中央病院（石川県）
岐阜県総合医療センター（岐阜県）
社会福祉法人聖隷福祉事業団 総合病院聖隷浜松病院（静岡県）
日本赤十字社愛知医療センター名古屋第一病院（愛知県）
日本赤十字社愛知医療センター名古屋第二病院（愛知県）
藤田医科大学病院（愛知県）
滋賀医科大学医学部附属病院（滋賀県）
長浜赤十字病院（滋賀県）
国立大学法人 京都大学医学部附属病院（京都府）
宗教法人 在日本南プレスビテリアンミッション 淀川キリスト教病院（大阪府）
社会福祉法人 石井記念愛染園附属愛染橋病院（大阪府）
大阪市立総合医療センター（大阪府）
姫路赤十字病院（兵庫県）
兵庫県立尼崎総合医療センター（兵庫県）
独立行政法人国立病院機構 岡山医療センター（岡山県）
岡山大学病院（岡山県）
県立広島病院（広島県）
独立行政法人 国立病院機構 四国こどもとおとなの医療センター（香川県）
香川大学医学部附属病院（香川県）
高知県・高知市病院企業団立高知医療センター（高知県）
高知大学医学部附属病院（高知県）
独立行政法人国立病院機構 佐賀病院（佐賀県）
長崎大学病院（長崎県）
宮崎大学医学部附属病院（宮崎県）
鹿児島市立病院（鹿児島県）
沖縄県立中部病院（沖縄県）
沖縄県立南部医療センター・こども医療センター（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 10 | 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
1149
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient and observation period
Very preterm infant or very low birth weight infant who admitted to research collaborating NICU from January 2021 to March 2024
1. Patient characteristics
NICU admission day(year/month), gestational age, birthweight, APGAR score, sex, grade of the Lencki criteria, preterm rupture of membrane for > 18hours, GBS carriage status at delivery, bacteremia at delivery, level of base excess at first blood gas analysis, temperature at NICU admission, degree of respiratory support at NICU admission
2. Assessment of antimicrobial stewardship
Blood culture sampling, blood culture result, antibiotics prescription, decision of cessation antibiotic therapy using early onset neonatal sepsis checklist
3. Patient prognosis
NICU discharge day(year/month), death during NICU stay, severe intraventricular hemorrhage, necrotizing enterocolitis, focal intestinal perforation/chronic lung disease at 36 weeks postconceptional age
Management information
Registered date
| 2023 | Year | 03 | Month | 08 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057548
