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ISRCTN
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ISRCTN59878178
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ClinicalTrials.gov identifier
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Public title
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Exploratory randomised double-blind controlled trial of breast milk fortifier with and without long chain polyunsaturated fatty acid (LCPUFA) supplementation on body composition in preterm infants
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Breast milk fortifier containing LCPUFA has a measurable effect upon body composition at term when compared with non-LCPUFA supplemented fortifier
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Preterm infants
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Participants - inclusion criteria
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Infants born at or below 32 weeks gestational age
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Participants - exclusion criteria
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1. Major congenital abnormality
2. Mother does not wish to provide breast milk or to use donor milk
3. Baby requires gastrointestinal surgery
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Anticipated start date
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01/08/2005
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Anticipated end date
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30/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120 of whom 42 will be randomised
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Interventions
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Infants will receive maternal +/- donor breast milk; should breast milk fortifier be indicated in accordance with normal clinical practice, infants will be randomised to receive standard fortifier or LCPUFA supplemented fortifier.
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Primary outcome measure(s)
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Body composition at age term-equivalent
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Secondary outcome measure(s)
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Growth, metabolic profile, intrahepatocellular lipid content, brain growth and development, neurological examination
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Sources of funding
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Numico Research Germany
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Trial website
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Publications
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Contact name
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Prof
Neena
Modi
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Address
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Imperial College London
Chelsea & Westminster Hospital
369 Fulham Road
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City/town
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London
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Zip/Postcode
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SW10 9NH
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Country
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United Kingdom
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Sponsor
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Milupa GmbH, Numico Research (Germany)
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Address
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Bahnstrasse 14-30
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City/town
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Friedrichsdorf
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Zip/Postcode
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61381
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Country
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Germany
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Date applied
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06/09/2005
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Last edited
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30/08/2007
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Date ISRCTN assigned
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13/09/2005
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