UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001728
Receipt number 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 14:10:26

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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 or person

Institute

Osaka Medical Center and Research Institute for Maternal and Child Health

Institute

Department

Personal name



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

Value
https://center6.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