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Completed

NCT Number: NCT02663453

Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

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.

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Key information

Conditions

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

Age range

24 week–30 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SMOF lipid

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.

Other names: Intralipid

Primary outcomes

  1. Incidence of Neonatal Cholestasis

    Time frame: 3 months

    direct bilirubin level of more than 2 mg/dL

Secondary outcomes

  1. Neonatal Morbidities

    Time frame: 4 months

    retinopathy of prematurity, bronchopulmonary dysplasia

  2. Incidence of Extrauterine Growth Restriction (EUGR)

    Time frame: up to 24 weeks

    weight that is less than the tenth percentile for corrected gestational age by the time of discharge

  3. Weight Gain

    Time frame: up to 24 weeks

    in-hospital weight gain at birth until discharge (gram/day)

  4. Height Gain

    Time frame: up to 24 weeks

    in-hospital height gain at birth until discharge (cm/week)

  5. Head Circumference Gain

    Time frame: up to 24 weeks

    in-hospital head circumference gain at birth until discharge (cm/week)

  6. Assessment of Gamma Glutamyltranspeptidase (GGT)

    Time frame: 3 month

    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration

  7. Assessment of Alanine Aminotransferase (ALT)

    Time frame: 3 month

    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration

  8. Assessment of Aspartate Aminotransferase (AST)

    Time frame: 3 month

    blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 26, 2016
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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