SCAMP: Standardised, concentrated, additional macronutrients, parenteral nutrition in very preterm infants: A phase IV randomised, controlled exploratory study of macronutrient intake,

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Infants born

Morgan et al BMC Pediatrics 2011, 11:53 http://www.biomedcentral.com/1471-2431/11/53 STUDY PROTOCOL Open Access SCAMP: standardised, concentrated, additional macronutrients, parenteral nutrition in very preterm infants: a phase IV randomised, controlled exploratory study of macronutrient intake, growth and other aspects of neonatal care Colin Morgan1*, Shakeel Herwitker2, Isam Badhawi3, Anna Hart4, Maw Tan5, Kelly Mayes6, Paul Newland6 and Mark A Turner1 Abstract Background: Infants born

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Từ khóa liên quan

Mục lục

Ethical and regulatory approval
Record of study participation
Methods: Treatment Regimen
- Study parenteral nutrition
- Description, labelling and storage of PN
- Assessment of compliance with study PN
- Methods: Assessments and Procedures
  - Study schedule
  - Intravenous/enteral nutrition, fluid and drug infusion data
  - Blood sampling and processing
  - Methods: Statistical Analysis
    - Sample size
    - Secondary analysis to facilitate interpretation of the primary outcome
    - Secondary analysis to characterise the trial
    - Discussion
      - Safety and adverse event reporting
      - Trial Oversight
        Data Monitoring and Ethics Committee (DMEC)
        Trial Steering Committee (TSC)

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