UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004225
Receipt number R000005079
Scientific Title Different feeding regimens and length of stay in preterm, small for gestational age, infants
Date of disclosure of the study information 2010/09/17
Last modified on 2014/11/05 04:08:58

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Basic information

Public title

Different feeding regimens and length of stay in preterm, small for gestational age, infants

Acronym

Proactive enteral nutrition in preterm SGA infants

Scientific Title

Different feeding regimens and length of stay in preterm, small for gestational age, infants

Scientific Title:Acronym

Proactive enteral nutrition in preterm SGA infants

Region

Europe


Condition

Condition

Prematurity, small for gestational age

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify if a proactive feeding regimen reduces length of stay in preterm, small for gestational age infants

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Total length of stay lower for infants in the proactive feeding regimen group

Key secondary outcomes

Faster regain of birth weight, lower incidence of metabolic problems, and lower need for intravenous infusion in the proactive feeding regimen group


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Human milk enteral intakes as follows: 100 ml/Kg/die at day of life 1, 130 ml/Kg/die at day of life 2, 165 ml/Kg/die at day of life 3, 200 ml/Kg/die from day of life 4 onward

Interventions/Control_2

Standard suggested feeding regimen for preterm infants

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

Gestational age 32 - 36 weeks
birth weigth > 1499 g
birth weigth Z Score < 1.28

Key exclusion criteria

Abnormal doppler velocimetry in fetal vessels
major congenital abnormality
neonatal congenital infective disease
respiratory distress syndrome
birth asphyxia

Target sample size

72


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Enrico Zecca

Organization

Catholic University of the Sacred Heart

Division name

Neonatology

Zip code


Address

Largo Gemelli 8, 00168 Rome, Italy

TEL

+81-039630154169

Email

enrizecca@rm.unicatt.it


Public contact

Name of contact person

1st name
Middle name
Last name Enrico Zecca

Organization

Catholic University of the Sacred Heart

Division name

Neonatology

Zip code


Address

Largo Gemelli 8, 00168 Rome, Italy

TEL

+81-039630154169

Homepage URL


Email

enrizecca@rm.unicatt.it


Sponsor or person

Institute

Division of Neonatology, Department of Pediatrics, Catholic University of the Sacred Heart

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Italy


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

Division of Neonatology, Department of Pediatrics, Catholic University of the Sacred Heart


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.jpeds.com/article/S0022-3476(14)00812-9/abstract

Number of participants that the trial has enrolled


Results

Proactive feeding regimen in moderately pretern SGA infants was were tollerated and significantly reduced the risk of hypoglycemia

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

2009 Year 09 Month 20 Day

Date of IRB


Anticipated trial start date

2009 Year 10 Month 01 Day

Last follow-up date

2013 Year 03 Month 31 Day

Date of closure to data entry

2013 Year 03 Month 31 Day

Date trial data considered complete

2013 Year 04 Month 15 Day

Date analysis concluded

2013 Year 10 Month 01 Day


Other

Other related information

Proactive feeding group had less need for intravenous fluids and shorter duration of phototherapy


Management information

Registered date

2010 Year 09 Month 17 Day

Last modified on

2014 Year 11 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005079


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name