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ISRCTN
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ISRCTN77444690
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ClinicalTrials.gov identifier
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Public title
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The Preterm Prebiotic Study
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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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NRG / II DbCoRPMc / PT EL 01
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Study hypothesis
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Supplementation of a preterm formula with 0.8 g galacto-oligosaccharides (GOS)/fructo-oligosacharides (FOS) mixture per dl (ratio: 9:1) will result in an improvement in enteral tolerance.
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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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United Kingdom
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Disease/condition/study domain
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Neonatal nutritional supplementation
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Participants - inclusion criteria
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Preterm infants, appropriately grown for gestational age, with a gestational age ≤32 + 6 weeks (days), whose mothers agree to the use of formula if they are unable to or do not wish to breast feed or are not able to provide sufficient breast milk
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Participants - exclusion criteria
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1. More than 72 hours exclusive parenteral nutrition
2. Immediately life-threatening congenital abnormality
3. Any condition requiring major surgery
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Anticipated start date
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01/10/2005
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Anticipated end date
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30/06/2007
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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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160
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Interventions
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Infants randomised to one of two groups receiving either Nutriprem A or B, one without and one with 0.8 g GOS/FOS oligosaccharides /dl, to make up any shortfall in their own mother’s milk or as sole diet if maternal milk is unavailable.
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Primary outcome measure(s)
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1. Number of days from birth to reach a total (sole formula or formula with breast milk) daily enteral intake of 150 ml/kg
2. Number of days between birth and 28 days that a total (sole formula or formula with breast milk) daily enteral intake of at least 150 ml/kg is tolerated
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Secondary outcome measure(s)
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1. Gain in weight, length and head circumference
2. Faecal flora
3. Faecal calprotectin
4. Faecal characteristics
5. Gastrointestinal tolerance
6. Fluid balance
7. Necrotising enterocolitis
8. Bloodstream infection
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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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20/08/2005
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Last edited
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07/10/2009
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Date ISRCTN assigned
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12/09/2005
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