Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

NCT02663453 | Completed Phase 3 Results DMC

• 1 other identifier: MTU-EC-PE-1-033/56
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cholestasis

Keywords

preterm; parenteral nutrition; cholestasis; fish oil

Outcome Measures

Primary Outcomes (1)

• Incidence of Neonatal Cholestasis

  direct bilirubin level of more than 2 mg/dL

  3 months

Secondary Outcomes (8)

• Neonatal Morbidities

  4 months

• Incidence of Extrauterine Growth Restriction (EUGR)

  up to 24 weeks

• Weight Gain

  up to 24 weeks

• Height Gain

  up to 24 weeks

• Head Circumference Gain

  up to 24 weeks

Study Arms (2)

study group

EXPERIMENTAL

multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; 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.The macronutrients and micronutrients were provided using the same products in both groups.

Drug: multicomponent lipid emulsion

control group

ACTIVE COMPARATOR

pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.

Drug: pure soybean oil lipid emulsion

Interventions

multicomponent lipid emulsion DRUG

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.

Also known as: SMOF lipid

study group

pure soybean oil lipid emulsion DRUG

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.

Also known as: Intralipid

control group

Eligibility Criteria

• Age: 24 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Inborn infants with a gestational age of less than 30 weeks
• Who required parenteral nutrition for at least 7 days

You may not qualify if:

• Evidence of congenital infection
• Perinatal asphyxia
• Congenital anomalies
• Severe IVH
• Thrombocytopenia
• Shock or circulation failure
• Renal or hepatic disorders.

Sponsors & Collaborators

• Thammasat University: lead

Related Publications (2)

• Tomsits E, Pataki M, Tolgyesi A, Fekete G, Rischak K, Szollar 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 infants requiring parenteral nutrition. J Pediatr Gastroenterol Nutr. 2010 Oct;51(4):514-21. doi: 10.1097/MPG.0b013e3181de210c.

  PMID: 20531018 RESULT

• 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 Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):81S-94S. doi: 10.1177/0148607111424411.

  PMID: 22237883 RESULT

MeSH Terms

Conditions

Cholestasis; Premature Birth; Hyperphagia

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr.Wilaiporn Techasatid
• Organization: Thammasat University

wilaiporn66@gmail.com

66890339442

Study Officials

• Wilaiporn Techasatid, doctor

  Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neonatology

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 26, 2016
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: June 23, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share