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ISRCTN
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ISRCTN13668937
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ClinicalTrials.gov identifier
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Public title
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A prospective, randomised pilot study in the management of neonates at risk of hypoglycaemia (34 weeks to term) by oral feeding using preterm formula.
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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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N0084144605
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Study hypothesis
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Preterm formula milk, having a higher calorie density than standard formula, is beneficial in maintaining blood glucose levels in neonates at high risk of hypoglycaemia.
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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 Diseases
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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05/04/2004
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Anticipated end date
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04/04/2005
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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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Convenience sampling will be used to accrue a minimum sample size of 20 neonates.
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Interventions
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Randomisation of at least 10 in each arm, routine management of cannulation and intravenous glucose or oral feeding of Preterm formula.
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Primary outcome measure(s)
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The two groups are compared using independent t-tests. So calculating means or proportions per group with 95% Cls for the difference between means or proportions as appropriate. If there is an element of repeated measures (i.e. if measuring each person more than once) then calculate the area under the curve (AUC) for each group and then compare the AUCs for binary categorical data odds ratios again with 95% CIs, can be used. Somewhere, an arbitrary level of 5% significance (two-tailed) will be assumed. Randomisation will be according to a random numbers table. Even split can not be done with a small sample. Due to small sample, the method of minimisation may be used, when randomising, or randomise using blocks.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
James
Devlin
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Address
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Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
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City/town
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Scunthorpe
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Zip/Postcode
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DN15 7BH
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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19/04/2011
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Date ISRCTN assigned
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30/09/2005
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