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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03013374 |
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Date of registration:
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30/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Protein Balance and Body Composition in Preterm Infants
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Scientific title:
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Protein Balance and Body Composition in Preterm Infants According to Feeding Regimen |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03013374 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Laura Morlacchi, MD |
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Address:
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Telephone:
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+39 0255032483 |
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Email:
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laura.morlacchi@mangiagalli.it |
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Affiliation:
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Name:
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Laura Morlacchi, MD |
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Address:
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Telephone:
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+39 0255032483 |
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Email:
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laura.morlacchi@mangiagalli.it |
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Affiliation:
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Name:
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Laura Morlacchi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- gestational age =32 weeks
- birth weight < 1500 grams
- birth weight =10th percentile according to Fenton's growth chart
- stable clinical conditions at discharge
- feeding by mouth with either exclusively human milk or formula at discharge
Exclusion Criteria:
- congenital or chromosomal abnormalities
- conditions that could interfere with growth such as chronic lung disease, neurological
disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or
sepsis (defined as a positive blood culture).
Age minimum:
23 Weeks
Age maximum:
32 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Human Milk
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PreTerm Birth
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Primary Outcome(s)
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Protein balance
[Time Frame: at hospital discharge (that is 35-36 post conceptional weeks)]
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Secondary Outcome(s)
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Fat free mass content
[Time Frame: Term corrected age (that is 40 post conceptional weeks)]
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Secondary ID(s)
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Protein balance and FFM
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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