deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT02579265

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

A Prospective, Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Requiring 28 Days of Parenteral Nutrition

Sponsor: Fresenius Kabi

Conditions Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Interventions Intralipid® 20% Smoflipid 20% (investigational lipid for parenteral nutrition)
Updated 15 times since 2017 Last updated: Dec 8, 2021 Started: Dec 31, 2015 Primary completion: Apr 3, 2020 Completion: Apr 10, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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.

Other terminated trials from Fresenius Kabi

See all terminations from Fresenius Kabi

This PHASE3 trial investigates Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days and is currently terminated or withdrawn. Fresenius Kabi leads this study, which shows 15 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshot~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshot~Mar 2019 – ~Oct 2019 · 7 months · monthly snapshot~Oct 2019 – ~Feb 2020 · 4 months · monthly snapshot~Feb 2020 – ~Jul 2020 · 5 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Dec 2021 · 6 months · monthly snapshot~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshot~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Feb 2022 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Dec 2021 — Feb 2022 [monthly]

    Terminated PHASE3

  5. Jun 2021 — Dec 2021 [monthly]

    Terminated PHASE3

▶ Show 10 earlier versions

  1. Apr 2021 — Jun 2021 [monthly]

    Terminated PHASE3

    Status: Completed → Terminated

  2. Jan 2021 — Apr 2021 [monthly]

    Completed PHASE3

  3. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  4. Feb 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  5. Oct 2019 — Feb 2020 [monthly]

    Recruiting PHASE3

  6. Mar 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  7. Jun 2018 — Mar 2019 [monthly]

    Recruiting PHASE3

  8. Aug 2017 — Jun 2018 [monthly]

    Recruiting PHASE3

  9. Feb 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  10. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Dec 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fresenius Kabi
Data source: Fresenius Kabi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Chicago, United States , Houston, United States , Nashville, United States , New Haven, United States , New York, United States , Oklahoma City, United States , Omaha, United States , Palo Alto, United States , Philadelphia, United States , Pittsburgh, United States and 1 more location