Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

Cholestasis Clinical Trial

Official title:

Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663453
• Other study ID #: MTU-EC-PE-1-033/56
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2016
• Last updated: January 21, 2016
• Start date: December 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.

Description:

Intravenous lipid emulsions are the major sources of non-protein energy and provision of required essential fatty acids.

The reference lipid emulsion, widely used for many years, is prepared from soybean oil, which is rich in omega 6 polyunsaturated fatty acids and phytosterols that contribute to hepatotoxicity and their metabolites result in pro-inflammatory eicosanoid production.

Existing evidence strongly supports a pathogenetic role of inflammation and oxidative stress on parenteral nutrition associated liver disease.

Subsequent development of lipid emulsions has focused on reducing the amount of soybean oil and replacing it with other oils.Moreover the omega 3 fatty acids from fish oil are metabolized to anti-inflammatory eicosanoids which can prevent inflammatory responses.

A novel multicomponent lipid emulsion may prevent liver injury, improve growth and decrease morbidity in preterm infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 30 Weeks

Eligibility

Inclusion Criteria:

• Inborn infants with a gestational age of less than 30 weeks

• Who required parenteral nutrition for at least 7 days

Exclusion Criteria:

• Evidence of congenital infection

• Perinatal asphyxia

• Congenital anomalies

• Severe IVH

• Thrombocytopenia

• Shock or circulation failure

• Renal or hepatic disorders.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis

Intervention

Drug:
• multicomponent lipid emulsion
Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
• pure soybean oil lipid emulsion
Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

References & Publications (2)

Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J — View Citation

Tomsits E, Pataki M, Tölgyesi A, Fekete G, Rischak K, Szollár L. Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of neonatal cholestasis	direct bilirubin level of more than 2 mg/dL	3 months	No
Secondary	Neonatal morbidities	retinopathy of prematurity, bronchopulmonary dysplasia	4 months	No
Secondary	Incidence of extrauterine growth restriction (EUGR)	weight that is less than the tenth percentile for corrected gestational age by the time of discharge	up to 24 weeks	No
Secondary	Weight gain	in-hospital weight gain at birth until discharge (gram/day)	up to 24 weeks	No
Secondary	Height gain	in-hospital height gain at birth until discharge (cm/week)	up to 24 weeks	No
Secondary	Head circumference gain	in-hospital head circumference gain at birth until discharge (cm/week)	up to 24 weeks	No
Secondary	Assessment of gamma glutamyltranspeptidase (GGT)	blood samples were obtained before enrollment, week 1, 2 and 3 (U/L)	3 month	No
Secondary	Assessment of alanine aminotransferase (ALT)	blood samples were obtained before enrollment, week 1, 2 and 3 (U/L)	3 month	No
Secondary	Assessment of aspartate aminotransferase (AST)	blood samples were obtained before enrollment, week 1, 2 and 3 (U/L)	3 month	No