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Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02579265
Recruitment Status : Terminated (Outcome of a planned interim analysis was that the sample size required to show superiority was too high to be feasible. Fresenius Kabi requested termination to the FDA on 17 Jan 2020. FDA accepted termination by written response on 16 Apr 2020.)
First Posted : October 19, 2015
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi

Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
Recruitment Status : Terminated
Actual Primary Completion Date : April 3, 2020
Actual Study Completion Date : April 10, 2020
Certification/Extension First Submitted : March 17, 2021
Submission Cycle Results Submitted to ClinicalTrials.gov Results Returned after Quality Control Review
1 August 20, 2021
September 15, 2021
2 September 30, 2021
October 28, 2021
3 November 4, 2021
December 1, 2021