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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026533
Receipt No. R000030470
Scientific Title Early oral stimulation and oral feeding skills in preterm infants: a randomized clinical trial
Date of disclosure of the study information 2017/07/01
Last modified on 2019/08/06

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Basic information
Public title Early oral stimulation and oral feeding skills in preterm infants: a randomized clinical trial
Acronym Early oral stimulation and oral feeding skills in preterm infants
Scientific Title Early oral stimulation and oral feeding skills in preterm infants: a randomized clinical trial
Scientific Title:Acronym Early oral stimulation and oral feeding skills in preterm infants
Region
Europe

Condition
Condition Preterm infants
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of early oral stimulation on oral feeding skills in preterm infants
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes time to reach total oral enteral feeding
Key secondary outcomes sucking pattern evaluation, lenght of hospital stays

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Early oral stimolations
Interventions/Control_2 Standard care
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Preterm infants with gestational age between 24 +0 and 31 +6 weeks
Key exclusion criteria Congenital malformation, genetic syndromes, major neurological injury
Target sample size 128

Research contact person
Name of lead principal investigator
1st name Francesca
Middle name
Last name Serrao
Organization Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Division name Division of neonatology
Zip code 00168
Address L.go A. Gemelli 8 00168 Roma Italy
TEL 393474081670
Email francesca.serrao@yahoo.it

Public contact
Name of contact person
1st name Francesca
Middle name
Last name Serrao
Organization Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Division name Division of neonatology
Zip code 00168
Address L.go A. Gemelli 8 00168 Roma Italy
TEL 393474081670
Homepage URL
Email francesca.serrao@yahoo.it

Sponsor
Institute Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Institute
Department

Funding Source
Organization No funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor No sponsor
Name of secondary funder(s) No sponsor

IRB Contact (For public release)
Organization Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Address Lgo A Gemelli 8 00168 Rome Italy
Tel +390630154357
Email francesca.serrao@policlinicogemelli.it

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 Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 01 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
Date of protocol fixation
2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2017 Year 07 Month 01 Day
Date of closure to data entry
2017 Year 07 Month 01 Day
Date trial data considered complete
2017 Year 07 Month 01 Day
Date analysis concluded
2017 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 13 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030470

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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