UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026533 |
|---|---|
| Receipt number | 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 15:46:33 |
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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
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
francesca.serrao@yahoo.it
Sponsor or person
Institute
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030470
