UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023211 |
|---|---|
| Receipt number | R000026759 |
| Scientific Title | Growth of head circumference in premature infants receiveing a multicomponent vs a soybean-based lipid emulsion: a randomized controlled trial. |
| Date of disclosure of the study information | 2016/07/18 |
| Last modified on | 2019/12/03 07:19:07 |
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Basic information
Public title
Growth of head circumference in premature infants receiveing a multicomponent vs a soybean-based lipid emulsion: a randomized controlled trial.
Acronym
Growth of head circumference in premature infants receiveing a multicomponent vs a soybean-based lipid emulsion.
Scientific Title
Growth of head circumference in premature infants receiveing a multicomponent vs a soybean-based lipid emulsion: a randomized controlled trial.
Scientific Title:Acronym
Growth of head circumference in premature infants receiveing a multicomponent vs a soybean-based lipid emulsion.
Region
| Europe |
Condition
Condition
Neonatology
Classification by specialty
| Pediatrics | Intensive care medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess head circumference growth in infants with birthweight less or equal than 1250 grams, receiving a multicomponent vs a soybean-based lipid emulsion from birth to 36 post-menstrual age or at discharge.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Variation of head circumference z-score from birth to 36 weeks of post-menstrual age or at discharge.
Key secondary outcomes
Variation of weight and lenght z-score from birth to 36 weeks of post-menstrual age or at discharge;
Incidence of late onset sepsis;
Incidence of cholestasis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
multicomponent lipid emulsion
Interventions/Control_2
soybean-based lipid emulsion
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
| 1 | days-old | > |
Gender
Male and Female
Key inclusion criteria
Premeture infants with birthweight < or equal than 1250 grams
Key exclusion criteria
major malformation syndromes,
post-hemmorrhagic hydrocephalus
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Costa Simonetta |
Organization
University Hospital "A. Gemelli", Rome, Italy
Division name
Neonatology
Zip code
Address
L.go A. Gemelli, 8 -00168, Rome, Italy
TEL
390630154357
simocosta@yahoo.it
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Costa Simonetta |
Organization
University Hospital "A. Gemelli", Rome, Italy
Division name
Neonatology
Zip code
Address
L.go A. Gemelli, 8 -00168, Rome, Italy
TEL
390630154357
Homepage URL
simocosta@yahoo.it
Sponsor or person
Institute
Prof Costantino Romagnoli
Department of Paediatrics
University Hospital "A. Gemelli", Rome, Italy
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 18 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026759
