UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033416 |
|---|---|
| Receipt number | R000038100 |
| Scientific Title | Neonatal E. coli Colonization in Premature Infants: Antibiotic Resistance and Virulence Characteristics |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2018/07/17 15:25:12 |
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Basic information
Public title
Neonatal E. coli Colonization in Premature Infants: Antibiotic Resistance and Virulence Characteristics
Acronym
Neonatal E. coli Colonization in Premature Infants: Antibiotic Resistance and Virulence Characteristics
Scientific Title
Neonatal E. coli Colonization in Premature Infants: Antibiotic Resistance and Virulence Characteristics
Scientific Title:Acronym
Neonatal E. coli Colonization in Premature Infants: Antibiotic Resistance and Virulence Characteristics
Region
| Japan |
Condition
Condition
Neonatal Sepsis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the prevalence, antibiotic susceptibility, and risk factors for E. coli colonization at birth in premature infants
Basic objectives2
Others
Basic objectives -Others
To characterize the pathogenicity of E. coli from premature infants and their mothers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of colonization for ampicillin-resistant E. coli and ESBL producing E. coli in premature infants and their mothers
Key secondary outcomes
Risk factor for neonatal E. coli colonization at birth
Rate of vertical transmission from mother to infant
Virulence factor of E. coli from premature infants and their mothers
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
| 1 | days-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inborn infants with birth weight <2 kg and/or gestational age (GA) <35 weeks admitted to the NICU between
Key exclusion criteria
Patients transferred to another hospital
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AYA KOIZUMI |
Organization
Gunma Children's Medical Center
Division name
Department of Neonatology
Zip code
Address
779 Shimohakoda, Sibukawa, Gunma, Japan
TEL
0279-52-3551
a-shio@mvi.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | AYA KOIZUMI |
Organization
Gunma Children's Medical Center
Division name
Department of Neonatology
Zip code
Address
779 Shimohakoda, Sibukawa, Gunma, Japan
TEL
0279-52-3551
Homepage URL
a-shio@mvi.biglobe.ne.jp
Sponsor or person
Institute
Department of Neonatology, Gunma Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Daido Life Welfare Foundation, Medical Research Program of Gunma Prefectural Government, Medical Research Program of Gunma Children's Medical Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
群馬大学医学部附属病院（群馬県）
桐生厚生総合病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 18 | 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
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
| 2014 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigated the prevalence and risk factors of antibiotic-resistant Escherichia coli (E. coli) colonization at birth in premature infants.
Management information
Registered date
| 2018 | Year | 07 | Month | 17 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038100
