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CompletedNCT02663453Updated Jun 23, 2017Results posted

Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

A Phase 3 interventional study of multicomponent lipid emulsion and pure soybean oil lipid emulsion in Cholestasis, sponsored by Thammasat University. Completed. Open to participants aged 24 Weeks to 30 Weeks. Per ClinicalTrials.gov, last updated 2017-06-23.

Sponsored by Thammasat University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
24 Weeks to 30 Weeks
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Cholestasis

Keywords

  • preterm
  • parenteral nutrition
  • cholestasis
  • fish oil
03

In context

Cholestasis

222 studies on the registry are indexed under Cholestasis; 36 are open to participants now.

This study's enrollment of 44 is below the median of 54 across 137 interventional studies indexed under Cholestasis.

Browse Cholestasis studies →

Lead sponsor

Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Weeks to 30 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Evidence of congenital infection
  • Perinatal asphyxia
  • Congenital anomalies
  • Severe IVH
  • Thrombocytopenia
  • Shock or circulation failure
  • Renal or hepatic disorders.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    study group

    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

  • Active comparator
    control group

    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

  • Drugmulticomponent 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.

    Also known as: SMOF lipid

  • Drugpure 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.

    Also known as: Intralipid

06

What researchers measure

Primary outcomes

  1. Incidence of Neonatal Cholestasis

    direct bilirubin level of more than 2 mg/dL

    Time frame: 3 months

Secondary outcomes

  1. Neonatal Morbidities

    retinopathy of prematurity, bronchopulmonary dysplasia

    Time frame: 4 months

  2. Incidence of Extrauterine Growth Restriction (EUGR)

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

    Time frame: up to 24 weeks

  3. Weight Gain

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

    Time frame: up to 24 weeks

  4. Height Gain

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

    Time frame: up to 24 weeks

  5. Head Circumference Gain

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

    Time frame: up to 24 weeks

  6. Assessment of Gamma Glutamyltranspeptidase (GGT)

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

    Time frame: 3 month

  7. Assessment of Alanine Aminotransferase (ALT)

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

    Time frame: 3 month

  8. Assessment of Aspartate Aminotransferase (AST)

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

    Time frame: 3 month

07

Results

Posted May 31, 2017

Participant flow

This study enrolled preterm infants who required parenteral nutrition for at least 7 days from 2 academic medical centers in Bangkok. The last patient completed in December 2015

Participant flow — Overall Study
MilestoneStudy GroupControl Group
Started2222
Completed1718
Not completed54
Withdrew: Death44
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryIncidence of Neonatal Cholestasis

direct bilirubin level of more than 2 mg/dL

Time frame:
3 months
Reported as:
Count of participants · Participants
Incidence of Neonatal Cholestasis
ParticipantsStudy GroupControl Group
Incidence of Neonatal Cholestasis12
SecondaryNeonatal Morbidities

retinopathy of prematurity, bronchopulmonary dysplasia

Time frame:
4 months
Reported as:
Count of participants · Participants
Neonatal Morbidities
ParticipantsStudy GroupControl Group
retinopathy of prematurity76
bronchopulmonary dysplasia109
SecondaryIncidence of Extrauterine Growth Restriction (EUGR)

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

Time frame:
up to 24 weeks
Reported as:
Count of participants · Participants
Incidence of Extrauterine Growth Restriction (EUGR)
ParticipantsStudy GroupControl Group
Incidence of Extrauterine Growth Restriction (EUGR)812
SecondaryWeight Gain

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

Time frame:
up to 24 weeks
Reported as:
Mean · gram/day
Weight Gain
gram/dayStudy GroupControl Group
Weight Gain19.7 ± 3.918.8 ± 3.9
SecondaryHeight Gain

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

Time frame:
up to 24 weeks
Reported as:
Mean · cm/week
Height Gain
cm/weekStudy GroupControl Group
Height Gain0.9 ± 0.20.8 ± 0.2
SecondaryHead Circumference Gain

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

Time frame:
up to 24 weeks
Reported as:
Mean · cm/week
Head Circumference Gain
cm/weekStudy GroupControl Group
Head Circumference Gain0.7 ± 0.20.7 ± 0.2
SecondaryAssessment of Gamma Glutamyltranspeptidase (GGT)

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

Time frame:
3 month
Reported as:
Mean · U/L
Assessment of Gamma Glutamyltranspeptidase (GGT)
U/LStudy GroupControl Group
before enrollment134.7 ± 113.8138.7 ± 62.6
week 173.8 ± 58.879.5 ± 45.4
week 263.1 ± 47.568.6 ± 43.5
week 394.0 ± 68.395.4 ± 85.2
SecondaryAssessment of Alanine Aminotransferase (ALT)

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

Time frame:
3 month
Reported as:
Mean · U/L
Assessment of Alanine Aminotransferase (ALT)
U/LStudy GroupControl Group
before enrollment16.3 ± 12.815.1 ± 7.1
week 114.7 ± 7.815.1 ± 7.2
week 217.1 ± 8.719.8 ± 13.3
week 317.5 ± 6.817.7 ± 7.9
SecondaryAssessment of Aspartate Aminotransferase (AST)

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

Time frame:
3 month
Reported as:
Mean · U/L
Assessment of Aspartate Aminotransferase (AST)
U/LStudy GroupControl Group
before enrollment61.8 ± 21.655.6 ± 28.1
week 126.5 ± 22.026.0 ± 9.6
week 226.2 ± 8.024.4 ± 6.2
week 324.2 ± 3.725.9 ± 8.8

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Study Group4/22 (18.2%)0/22 (0%)0/22 (0%)
Control Group4/22 (18.2%)0/22 (0%)0/22 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(weeks)Study GroupControl GroupTotal
Mean27.6 ± 2.228.4 ± 1.228.0 ± 1.8
Sex: Female, Male
Sex: Female, Male(Participants)Study GroupControl GroupTotal
Female141428
Male8816
Region of Enrollment
Region of Enrollment(participants)Study GroupControl GroupTotal
Thailand222244
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 20531018 ↗
  • 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. PubMed 22237883 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02663453
Lead sponsor
Thammasat University
Responsible party
Dr Wilaiporn Techasatid (Head of Neonatology, Thammasat University) — Principal investigator
First posted
Jan 26, 2016
Start date
Dec 2013
Primary completion
Dec 2015
Completion
Jan 2016
Results posted
May 31, 2017
Last update
Jun 23, 2017

Study contacts

Wilaiporn Techasatid, doctor
principal investigator · Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: SMOFlipid

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