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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004225
Receipt No. 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

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

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
URL(English) https://upload.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


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