CholestasisPhase 3NCT02663453
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
A Phase 3 study testing multicomponent lipid emulsion and pure soybean oil lipid emulsion in people with Cholestasis, run by Thammasat University.
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… Read more about this study
- Who is it for?
- Ages 24 to 30 weeks
- Conditions the study is for
- Cholestasis
- What is being tested?
- multicomponent lipid emulsion and pure soybean oil lipid emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jan 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn infants with a gestational age of less than 30 weeks
- Who required parenteral nutrition for at least 7 days
Who cannot join
- Evidence of congenital infection
- Perinatal asphyxia
- Congenital anomalies
- Severe IVH
- Thrombocytopenia
- Shock or circulation failure
- Renal or hepatic disorders.
About this study
Official title: Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial
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.
- Conditions
- Cholestasis
- Being tested
- multicomponent lipid emulsion, pure soybean oil lipid emulsion
- Keywords
- preterm, parenteral nutrition, cholestasis, fish oil
- Medical subject headings
- Cholestasis, Premature Birth, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent lipid emulsionDrug
Also called SMOF lipid
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 emulsionDrug
Also called Intralipid
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: pure soybean oil lipid emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Neonatal Cholestasis
direct bilirubin level of more than 2 mg/dL
Measured: 3 months
Secondary outcomes (8)
Neonatal Morbidities
retinopathy of prematurity, bronchopulmonary dysplasia
Measured: 4 months
Incidence of Extrauterine Growth Restriction (EUGR)
weight that is less than the tenth percentile for corrected gestational age by the time of discharge
Measured: up to 24 weeks
Weight Gain
in-hospital weight gain at birth until discharge (gram/day)
Measured: up to 24 weeks
Height Gain
in-hospital height gain at birth until discharge (cm/week)
Measured: up to 24 weeks
Head Circumference Gain
in-hospital head circumference gain at birth until discharge (cm/week)
Measured: up to 24 weeks
Assessment of Gamma Glutamyltranspeptidase (GGT)
blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Measured: 3 month
Assessment of Alanine Aminotransferase (ALT)
blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Measured: 3 month
Assessment of Aspartate Aminotransferase (AST)
blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholestasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Wilaiporn Techasatid, Thammasat University
- Investigators
- Wilaiporn Techasatid, doctor, Principal investigator, Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663453
- Sponsor's protocol ID
- MTU-EC-PE-1-033/56
- Status last verified
- May 2017
- First submitted
- 11 Jan 2016
- Last updated
- 23 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 20531018Rayyan 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02663453
- Acronym / sponsor ID
- MTU-EC-PE-1-033/56
- Conditions
- Cholestasis
- Keywords
- preterm, parenteral nutrition, cholestasis, fish oil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: multicomponent lipid emulsionmulticomponent 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. |
| control group | Active comparator | Drug: pure soybean oil lipid emulsionpure 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. |
Who may qualify
- Ages
- 24 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Inborn infants with a gestational age of less than 30 weeks
- Who required parenteral nutrition for at least 7 days
Key exclusion criteria (7 listed)
- Evidence of congenital infection
- Perinatal asphyxia
- Congenital anomalies
- Severe IVH
- Thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multicomponent lipid emulsionAlso: SMOF lipidLipids 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. | Drug | study group |
| pure soybean oil lipid emulsionAlso: IntralipidLipids 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. | Drug | control group |
Primary outcome
Incidence of Neonatal Cholestasis
Time frame: 3 months
direct bilirubin level of more than 2 mg/dL
8 secondary outcomes
Neonatal Morbidities
Time frame: 4 months
Incidence of Extrauterine Growth Restriction (EUGR)
Time frame: up to 24 weeks
Weight Gain
Time frame: up to 24 weeks
Height Gain
Time frame: up to 24 weeks
Head Circumference Gain
Time frame: up to 24 weeks
Assessment of Gamma Glutamyltranspeptidase (GGT)
Time frame: 3 month
Assessment of Alanine Aminotransferase (ALT)
Time frame: 3 month
Assessment of Aspartate Aminotransferase (AST)
Time frame: 3 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20531018Tomsits 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.
- Results publication: PubMed 22237883Rayyan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilaiporn Techasatid, doctor principal investigator
Department of Pediatrics, Faculty of Medicine, Thammasat University, 95 Paholyothin Road, Klongluang, Pathumthani, 12120 Thailand.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing multicomponent lipid emulsion and pure soybean oil lipid emulsion in people with Cholestasis, run by Thammasat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Neonatal Cholestasis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663453, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.