UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neonatal E. coli Colonization in Premature Infants: Antibiotic Resistance and Virulence Characteristics
Title of the study (Brief title)	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	AYA KOIZUMI
Organization	Gunma Children's Medical Center
Division name	Department of Neonatology
Address	779 Shimohakoda, Sibukawa, Gunma, Japan
TEL	0279-52-3551
Email	a-shio@mvi.biglobe.ne.jp

Public contact
Name of contact person	AYA KOIZUMI
Organization	Gunma Children's Medical Center
Division name	Department of Neonatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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