A Multicenter, Non-interventional, Uncontrolled, Open-label, Observational Study in Children (up to Age 24 Months) to Evaluate Serum Mg Levels Associated with the Intake of Numeta G 16% E (NUMETA G 16% E)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional, observational risk assessment

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B05BA10) combinations

  combinations

Population studied

• Short description of the study population:
  Children (up to Age 24 Months) with the Intake of Numeta G 16% E.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The primary objective of this study is to generate descriptive data for serum Mg levels in full-term, new born infants and children up to 24 months of age following dosing with Numeta G 16% E.
• Outcomes:
  Influence of Numeta on the serum Magnesium levels to new born infants and children up to 24 months of age receiving Numeta G16%E, Yes, there are the following secondary endpoints/outcomes as per protocol, however reflected as 'Other Variables' in CSR:-Daily Product Intake (ml/kg/day)-Nutrition Intake (calories by oral, enteral, parenteral)
• Data analysis plan:
  The full analysis set (FAS) will include all subjects who received at least 1 dose of Numeta. All subjects who received 5 days of treatment with Numeta G 16% E and who have a baseline and a postdose serum Mg level will be included in the primary analysis set (PAS).