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

Phase 3TerminatedNCT02579265

Fresenius Kabi204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

204

Conditions

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

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.

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.

Eligibility

Sex: ALLMin age: 0 Weeks

Medical Language ↔ Plain English

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

Locations (13)

Lucile Packard Children's Hospital

Palo Alto, California, United States

UC San Diego Medical Center

San Diego, California, United States

Rady Children's Hospital San Diego

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Body Weight (Change From Baseline)

Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).

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

Body Length (Change From Baseline)

Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).

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

Head Circumference (Change From Baseline)

Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).

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

Time to Full Enteral or Oral Feeds

Time to full enteral or oral feeds (i.e. PN weaning) is the time from the randomization date to the date of the first full enteral or oral Feeds.

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

Data from ClinicalTrials.gov

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