UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033416
Receipt No. 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

* 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 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
Email 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
Email a-shio@mvi.biglobe.ne.jp

Sponsor
Institute Department of Neonatology, Gunma Children's Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038100

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.