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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001728
Receipt No. R000002082
Scientific Title Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Date of disclosure of the study information 2009/03/01
Last modified on 2009/02/23

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Basic information
Public title Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Acronym Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Scientific Title Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Scientific Title:Acronym Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Region
Japan

Condition
Condition Extremely Low Birth Weight Infants
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective was to study the efficacy and safety of transpyloric tube feeding compared with gastric tube feeding on the respiratory deterioration in intubated extremely low birth weight infants.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Chronic lung disease, additional oxygen requirement at 36weeks post conceptional age
failure criteria,respiratory deterioration and intestinal disorder
Key secondary outcomes Chronic lung disease, additional oxygen requirement at 28day of life
Mean Airway Pressure on ventilator
FiO2
FSp95,FiO2 to keep SpO2>95% at rest
RAS,Room Air Saturation
Growth and Development

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 transpyloric tube feeding group
Interventions/Control_2 gastric tube feeding group
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
0 weeks-old <=
Age-upper limit
0 weeks-old >=
Gender Male and Female
Key inclusion criteria birth weight less than 1000g
less than 28 weeks gestation
mechanical ventilation had been performed
enteral feeding had been reached 50ml/kg/day
parental consent
Key exclusion criteria intestinal disorder including necrotizing enterocolitis
congenital anomalies such as chromosomal anomalies
congenital heart diseases
hydrops
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Tanaka
Organization Osaka Medical Center and Research Institute for Maternal and Child Health
Division name Departments of Neonatology
Zip code
Address 840 Murodou-cho, Izumi-city, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka Medical Center and Research Institute for Maternal and Child Health
Division name Departments of Neonatology
Zip code
Address
TEL
Homepage URL
Email s-tanaka@bca.bai.ne.jp

Sponsor
Institute Osaka Medical Center and Research Institute for Maternal and Child Health
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2001 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2001 Year 06 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 23 Day
Last modified on
2009 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002082

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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