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 identification

• EU PAS number:
  EUPAS7113
• Study ID:
  23227
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Sweden
• Study description:
  This non-interventional, observational study is being undertaken to generate data to assess the impact of Numeta G 16% E on serum magnesium (Mg) levels in full-term, new born infants and children up to 24 months of age who require >70% parenteral nutrition (PN) at study entry and who are expected to require at least 50% PN for 5 days.
• Study status:
  Finalised

Research institutions and networks

Institutions

Baxter Healthcare Corporation

Multiple centres: 11 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:30/06/2014

Actual:30/06/2014

Study start date

Planned:01/12/2014

Actual:16/12/2014

Date of interim report, if expected

Planned:01/02/2016

Actual:01/02/2016

Date of final study report

Planned:31/12/2018

Actual:29/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxter Healthcare Corporation

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)