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
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
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
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
