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



Status:Recruiting
Healthy:No
Age Range:Any
Updated:2/8/2019
Start Date:December 2015
End Date:October 2019
Contact:John F Stover, MD
Email:john.stover@fresenius-kabi.com
Phone:+49 6172 686

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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

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.


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
We found this trial at
14
sites
3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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San Diego, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Pittsburgh, PA
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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Nashville, TN
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New Haven, Connecticut 06511
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New Haven, CT
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New York, NY
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New York, New York 10029
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Palo Alto, California 94304
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San Diego, California 92103
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San Diego, CA
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