NCT02579265

Brief Summary

To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment, confirmed by a second sample collected 7 days after the first sample.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 5, 2022

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

4.3 years

First QC Date

October 15, 2015

Results QC Date

August 20, 2021

Last Update Submit

December 8, 2021

Conditions

Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days

Keywords

Parenteral nutritionNeonatesInfantsLipid emulsionsIntravenous

Outcome Measures

Primary Outcomes (1)

  • The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample

    Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.

    Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl

Secondary Outcomes (15)

  • Body Weight (Change From Baseline)

    Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up)

  • Body Length (Change From Baseline)

    Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up

  • Head Circumference (Change From Baseline)

    Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up

  • Time to Full Enteral or Oral Feeds

    Day 29/end of treatment, if continued: Day 85/end of treatment

  • Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)

    Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment

  • +10 more secondary outcomes

Study Arms (2)

Smoflipid 20%

EXPERIMENTAL

Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".

Drug: Smoflipid 20% (investigational lipid for parenteral nutrition)

Intralipid® 20%

ACTIVE COMPARATOR

Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".

Drug: Intralipid® 20%

Interventions

Smoflipid 20% (investigational lipid for parenteral nutrition)DRUG

Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Smoflipid 20% will be infused into a central or a peripheral vein.

Also known as: Smoflipid 20% (lipid injectable emulsion)
Smoflipid 20%
Intralipid® 20%DRUG

Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day. Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate. Intralipid® 20% will be infused into a central or peripheral vein.

Also known as: Intralipid® 20% (a 20% intravenous fat emulsion)
Intralipid® 20%

Eligibility Criteria

Age0 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Neonates and infants, expected to require parenteral nutrition (PN) for 28 days
  • Postmenstrual age ≥ 24 weeks
  • Birth weight ≥ 750g
  • Gastroschisis, duodenal, jejunal or ileal atresia, volvulus, spontaneous intestinal perforation or necrotizing enterocolitis (Bell's stage 2B or higher)
  • At least 80% of nutritional needs at baseline received by PN
  • Signed and dated informed consent obtained from at least one parent or legal guardian

You may not qualify if:

  • Conjugated bilirubin \> 0.6 mg/dL
  • Any known pre-, intra- or posthepatic complication increasing conjugated bilirubin levels \> 0.6, mg/dL during study participation
  • Suspected liver disease or liver damage based on either aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) exceeding 2.5x upper limit of normal range
  • Active bloodstream infection demonstrated by positive blood culture at screening
  • Cystic fibrosis
  • Meconium ileus
  • Serum triglyceride levels \> 250 mg/dL
  • Cyanotic congenital heart defect
  • Severe renal failure with serum creatinine \> 2.0 mg/dL
  • History of shock requiring vasopressors
  • Anasarca
  • Extracorporeal Membrane Oxygenation (ECMO)
  • Known inborn errors of metabolism
  • Known congenital viral infection
  • Unlikely to survive longer than 28 days
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

UC San Diego Medical Center

San Diego, California, 92103, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Yale - New Haven Children's Hospital

New Haven, Connecticut, 06510, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2991, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-1205, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Steven & Alexandra Cohen Children's Medical Center of NY

New York, New York, 11040, United States

Location

The Children's Hospital at OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Vanderbilt Children's Hospital

Nashville, Tennessee, 37345, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Abrams SA, Ernst KD, Weitkamp JH, Mascarenhas M, Anderson-Berry A, Rudolph J, Ling CY, Robinson DT, Shores D, Hair AB, Lai J, Lane B, McCallie KR, Levit O, Kim JH. Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring Prolonged Parenteral Nutrition - A Randomized, Double-Blind, Multicenter, Controlled Trial. J Nutr. 2024 Dec;154(12):3615-3625. doi: 10.1016/j.tjnut.2024.10.005. Epub 2024 Oct 5.

    PMID: 39374788DERIVED

MeSH Terms

Conditions

Hyperphagia

Interventions

SMOFlipidParenteral Nutritionsoybean oil, phospholipid emulsionFat Emulsions, Intravenous

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyEmulsionsColloidsDosage FormsPharmaceutical PreparationsParenteral Nutrition SolutionsPharmaceutical SolutionsSolutionsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

Title
Dr. Jean-Marc Lohse, Director Clinical Operations PN NAM & ELAMA
Organization
Fresenius Kabi Deutschland GmbH
Jean-Marc.Lohse@fresenius-kabi.com
+49 6172 686

Study Officials

  • Steven A Abrams, MD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 19, 2015

Study Start

December 1, 2015

Primary Completion

April 3, 2020

Study Completion

April 10, 2020

Last Updated

January 5, 2022

Results First Posted

January 5, 2022

Record last verified: 2021-12

Locations

US(13)