Phase 3 N=48 Randomized Prevention

Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

Cholestasis of Parenteral Nutrition

Bottom Line

View on ClinicalTrials.gov: NCT03387579 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Aug 2022

Primary outcome: Primary: Number of Participants With Cholestasis — 1; 3; 7 Participants — p=0.590

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Smoflipid 20% Lipid Emulsion for Injection (Drug); Intralipid, 20% Intravenous Emulsion (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Indiana University
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Cholestasis	1; 3; 7	0.590
SECONDARY Weight Velocity	28.6; 23.0; 24.6	0.471
SECONDARY Length Velocity	0.13; 0.09; 0.10	0.525
SECONDARY Head Circumference (OFC) Velocity	0.09; 0.07; 0.10	0.753
SECONDARY Average Total Calorie Intake	114.0; 101.9; 109.1	0.008 sig
SECONDARY Number of Patients With Enteral Autonomy at End of Study	9; 10; 23	0.127
SECONDARY Number of Patients With Essential Fatty Acid Deficiency (EFAD)	0; 1	1.00
SECONDARY AST Change Over Time	-8.3; 2.9; 5.1	0.046 sig
SECONDARY ALT Change Over Time	8.7; 25.3; 17.2	0.003 sig
SECONDARY Alkaline Phosphatase Change Over Time	107.0; 166.1; 150.2	0.006 sig
SECONDARY Triglyceride Level Over Time	-18.5; 013.3; 13.7	0.835
SECONDARY Gamma Glutamyl Transferase (GGT) Over Time	-0.8; 55.7; 37.3	0.379
SECONDARY Number of Patients With Retinopathy of Prematurity	2; 1; 3	1.00
SECONDARY Number of Patients With Bronchopulmonary Dysplasia (BPD) or Chronic Lung Disease	2; 2; 5	1.00
SECONDARY NICU Length of Stay	72.2; 33.3; 40.2	0.211
SECONDARY Three Year Development- Communication	40.3; 41.2	0.720
SECONDARY Three Year Development: Gross Motor	43.0; 54.1	0.500
SECONDARY Three Year Development: Fine Motor	32.2; 34.9	0.774
SECONDARY Three Year Development: Problem Solving	47.9; 47.3	0.457
SECONDARY Three Year Development: Personal Social	46.5; 47.1	0.475

Summary

Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.

Eligibility Criteria

Inclusion Criteria: Neonates with anticipated need for parenteral nutrition (based on primary physicians opinion) for greater than or equal to four weeks and one of the following diagnoses:

Anatomic: Neonate with intestinal atresia, omphalocele, gastroschisis, or volvulus with or without intestinal resection.
Ischemic/perforation: Neonates with spontaneous intestinal perforation or necrotizing enterocolitis requiring surgical intervention.

Exclusion Criteria

Current weight less than 750 grams
AST or ALT greater than 5 times the upper limit of normal within 2 weeks of enrollment
Direct bilirubin greater than 2 mg/dL on any consecutive measurements 5 - 7 days apart within 2 weeks of enrollment
Severe coagulopathy with INR greater than 95th percentile for age (>1.7 at less than 5 days of age, > 1.5 older than five days of age)
Culture confirmed sepsis with positive blood, urine, or CSF culture within 2 weeks of enrollment
Renal failure requiring dialysis
Cyanotic heart disease requiring prostaglandin therapy
Hypertriglyceridemia (greater than 250mg/dL) at time of enrollment

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Data sourced from ClinicalTrials.gov (NCT03387579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.