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

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 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

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

Value
https://center6.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