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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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ISRCTN |
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Last refreshed on:
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18 June 2018 |
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Main ID: |
ISRCTN27916681 |
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Date of registration:
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11/02/2015 |
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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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Effect on body and brain development of feeding very premature babies with breast milk containing different supplements
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Scientific title:
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Effect of different composition of human milk and its fortification in body composition and neurodevelopment in a cohort of very preterm infants: a observational cohort study |
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Date of first enrolment:
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01/02/2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN27916681 |
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Study type:
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Observational |
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Study design:
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Prospective observational cohort study (Treatment)
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Phase:
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Israel
Macedo |
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Address:
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Alam Qta Sto Antonio 5-N3-2Esq
1600-675
Lisbon
Portugal |
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Telephone:
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Email:
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Affiliation:
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Name:
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Address:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Preterms with less 34 weeks gestational age
Exclusion criteria: 1. Congenital malformations
2. Formula feeding
3. Inability to achieve full enteral feeding
4. Parents inability to understand informed consent
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Body composition, BSDI II at 12 and 18 months
Nutritional, Metabolic, Endocrine
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Intervention(s)
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1. Normal variation in human milk composition
2. Blind fortification plus protein supplementation - caregivers and evaluators blind to macronutrient composition.
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Primary Outcome(s)
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1. Body composition by plethysmography at 40 weeks
2. Bayley Scales of Infant Development II (BSDI II) at 18 months
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Secondary Outcome(s)
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Neonatal morbidities
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Source(s) of Monetary Support
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Milupa Portugal, Lda
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Ethics review
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Status:
Approval date:
Contact:
1. Hospital Board Ethics approval, 16/05/2012, ref: Nr 116/2012
2. A Comissão de Ética da NMS|FCM-UNL, 01/10/2015, ref: 75/2014/CEFCM
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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28/02/2015 |
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URL:
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