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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023211
Receipt No. 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 2016/07/18

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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
Email 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
Email simocosta@yahoo.it

Sponsor
Institute Prof Costantino Romagnoli
Department of Paediatrics
University Hospital "A. Gemelli", Rome, Italy
Institute
Department

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
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

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 Preinitiation
Date of protocol fixation
2016 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 18 Day
Last modified on
2016 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026759

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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