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

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ClinicalTrials.gov Identifier: NCT02579265
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi

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.

Condition or disease Intervention/treatment Phase
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days Drug: Smoflipid 20% (investigational lipid for parenteral nutrition) Drug: Intralipid® 20% Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : December 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smoflipid 20%
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)

Dose: The targeted maximal lipid dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the lipid 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.

Investigational or control drug will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.

The lipid emulsions will be infused into a central or peripheral vein.


Active Comparator: Intralipid® 20%
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%

Dose: The targeted maximal lipid dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the lipid 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.

Investigational or control drug will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.

The lipid emulsions will be infused into a central or peripheral vein.





Primary Outcome Measures :
  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 [ Time Frame: Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl ]

Secondary Outcome Measures :
  1. Body weight (change from Baseline) [ Time Frame: Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up) ]
  2. Body length (change from Baseline) [ Time Frame: 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 ]
  3. Head circumference (change from Baseline) [ Time Frame: 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 ]
  4. Time to full enteral or oral feeds [ Time Frame: Day 29/end of treatment, if continued: Day 85/end of treatment ]
  5. Fatty acids in plasma and red blood cell membranes (change from Baseline) [ Time Frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment ]
  6. Length of stay in hospital [ Time Frame: Day 1- Follow up (7 days after end of treatment) ]
  7. Ratio of number of independent bloodstream infections to number of days on study medication [ Time Frame: Day 1-29 or -85 if continued + Follow-up ]
  8. Ratio of the number of patients with 1 or more bloodstream infections to number of patients on study medication [ Time Frame: Day 1-29 or -85 if continued + Follow-up ]
  9. Number of patients who complete PN treatment without lipid minimization [ Time Frame: Day 1-29 or -85 if continued + Follow-up ]
  10. Number of patients needing to be withdrawn from the study due to elevated conjugated bilirubin levels [ Time Frame: Day 1-29 or -85 if continued + Follow-up ]
  11. Cumulative number of days of conjugated bilirubin levels > 1.5 mg/dL [ Time Frame: Day 1-29 or -85 if continued + Follow-up ]
  12. Area under the curve for time period in which conjugated bilirubin levels are > 1.5 mg/dL in patients who are not withdrawn from the study [ Time Frame: Day 1-29 or -85 if continued + Follow-up ]
  13. Cumulative number of days patients are administered a lipid dose without lipid minimization [ Time Frame: Day 1-29 or -85 if continued + Follow-up ]
  14. Time to conjugated bilirubin > 2 mg/dL (confirmed by a second sample collected 7 days after the first [ Time Frame: Day 1-29 or -85 if continued + Follow-up ]
  15. Collection of AE data [ Time Frame: After randomization/Day 1-29 or -85: - Follow-up (7 days after end of treatment) ]
  16. Blood sampling for safety analysis [ Time Frame: Screening, Day 8, 15, 22, 29/end of treatment, if continued: Day 43, 57, 71, 85/end of treatment ]
    (conjugated bilirubin, total bilirubin, serum triglycerides, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, blood glucose, blood urea nitrogen, creatinine, C-reactive protein)

  17. Blood sampling for special analysis (sterols including phytosterols, α-tocopherol) [ Time Frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment ]
  18. Holman index [ Time Frame: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Known hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579265


Contacts
Contact: John F Stover, MD +49 6172 686 ext 4598 john.stover@fresenius-kabi.com
Contact: Steffen Benzing, PhD +49 6172 686 ext 7709 steffen.benzing@fresenius-kabi.com

Locations
United States, California
Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Katherine McCallie, MD         
UC San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Jae H Kim, MD, PhD         
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Brian Lane, MD         
United States, Connecticut
Yale - New Haven Children's Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Orly Levit, MD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611-2991
Contact: Daniel T Robinson, MD         
United States, Massachusetts
Boston Children's Hospital Withdrawn
Boston, Massachusetts, United States, 02115
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-1205
Contact: Ann Anderson Berry, MD, PhD         
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Joanne Lai, MD         
Steven & Alexandra Cohen Children's Medical Center of NY Active, not recruiting
New York, New York, United States, 11040
United States, Oklahoma
The Children's Hospital at OU Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kimberly Ernst, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maria R Mascarenhas, MBBS         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Jeffrey A Rudolph, MD         
United States, Tennessee
Vanderbilt Children's Hospital Recruiting
Nashville, Tennessee, United States, 37345
Contact: William Walsh, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Amy B Hair, MD         
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Steven A Abrams, MD Dell Medical School at The University of Texas at Austin

Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT02579265     History of Changes
Other Study ID Numbers: SMOF-018-CP3
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Keywords provided by Fresenius Kabi:
Parenteral nutrition
Neonates
Infants
Lipid emulsions
Intravenous

Additional relevant MeSH terms:
Soybean oil, phospholipid emulsion
Parenteral Nutrition Solutions
Fat Emulsions, Intravenous
Pharmaceutical Solutions