Preterm InfantPhase 4NCT01683162
Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants
A Phase 4 study testing ClinOleic, Lipofundin and Intralipid in people with Preterm Infant, run by Wei Cai at 1 site in China.
Trial summary
Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in preterm infants, a showed efficacy and a good clinical and biological safety profile. The objective of this study was to assess the effects of a new olive-oil based lipid emulsion compared with the traditional lipid emulsions. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Preterm Infant
- What is being tested?
- ClinOleic, Lipofundin and Intralipid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants of both genders
- Hospitalized
- The parent of the infant agreed to participate by signing an informed consent form
- Infants admitted hospital within 72 hours after birth(gestational age<37 weeks)
- Birth weight <= 2000g
- No PN support contraindications
- Parenteral nutrition for 14 days or more
- The parent of the infant is to sign an informed consent form prior to enrollment
Who cannot join
- Receiving PN before screening
- EN caloric>10%
- Obstruction jaundice
- Suspected or identified biliary tract atresia
- Neonatal hepatitis
- Infants with liver markers >2 times normal levels
Show all 11Show fewer
- Infants with renal markers >2 times normal levels
- Congenital metabolic situations
- Identified as having major chromosomal disease
- CMV, virus hepatitis and syphilis infection
- Congenital or acquired immune deficiency
Trial locations and contacts
1 site in 1 country.
Wei Cai, Phd contact
China1 site, 1 recruiting
- Recruiting
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200092
Ying Wang, Phd, 8613611884226, wangying_ssmu@126.com
Wei Cai, Phd, caiw204@yahoo.com.cn
About this study
Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in preterm infants, a showed efficacy and a good clinical and biological safety profile. The objective of this study was to assess the effects of a new olive-oil based lipid emulsion compared with the traditional lipid emulsions.
Read the detailed description
For a number of years, lipid emulsions have been used in the nutritional support of surgical and critically ill patients, with the aim of supplying substrates to meet energy demands and providing building blocks for wound healing and tissue repair. Two types of lipid emulsions are currently used for adult as well as pediatric patients: one lipid emulsions prepared from soybean oil that are composed of long-chain triacylglycerols (LCTs), 62% of which are polyunsaturated fatty acids (PUFAs), and the other lipid emulsions composed of 50% medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion (20%) of PUFAs and 60% monounsaturated fatty acids (MUFAs). There are so many investigations with olive oil-based emulsion including in-vitro studies, animal studies, and infusion studies in healthy subjects and in various patient groups. In-vitro and animal studies demonstrate that the impairment of immune function, especially of T cell responses, that occurs with soybean oil-based emulsions is avoided with ClinOleic. Studies in infants and adults have consistently shown that olive oil-based emulsion increases the oleic acid content of blood lipids and that it avoids the depletion of long chain n-6 PUFA derivatives of linoleic acid that is seen with soybean oil-based emulsion. The less unsaturated nature of olive oil-based emulsion compared will possibly decrease oxidative stress. Further studies are required to test their beneficial effect from olive oil consumption in preterm infants.
The investigators designed a double-blind, randomized clinical trial to performed the effect of lipometabolism, oxidative stress and clinical outcomes of olive oil , MCY/LCT and LCT lipid emulsions.
- Conditions
- Preterm Infant
- Being tested
- ClinOleic, Lipofundin, Intralipid
- Keywords
- parenteral nutrition, lipid emulsion, olive oil, liver function, fatty acid, clinical outcomes
- Medical subject headings
- Premature Birth, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinOleicDrug
the lipid of all-in-one, 0.5-3.5g/kg.d
LipofundinDrug
the lipid of all-in-one, 0.5-3.5g/kg.d
IntralipidDrug
the lipid of all-in-one, 0.5-3.5g/kg.d
| Study group | Role | What they receive |
|---|---|---|
| Olive oil lipid emulsion | Experimental | the olive oil lipid emulsion is ClinOleic Receives: Drug: ClinOleic |
| MCT/LCT lipid emulsion | Experimental | the MCT/LCT lipid emulsion is Lipofundin Receives: Drug: Lipofundin |
| LCT lipid emulsion | Experimental | the LCT lipid emulsion is Intralipid Receives: Drug: Intralipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipometabolism
fatty acid
Measured: Change from Baseline in fatty acid at 7 days and 14 days
Secondary outcomes (1)
oxidative stress
superoxidase dismutase(SOD),malondialdehyde(MDA),glutathione peroxidase(GSH-Px),total-anti-oxidizing-capability(T-AOC)
Measured: Change from Baseline in liver function at 7 days and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Cai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Cai, Shanghai Jiao Tong University School of Medicine
- Investigators
- Ying Wang, phd, Principal investigator, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683162
- Sponsor's protocol ID
- PNDLEIPI
- Status last verified
- Sep 2012
- First submitted
- 18 Jul 2012
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Y, Feng Y, Lu LN, Wang WP, He ZJ, Xie LJ, Hong L, Tang QY, Cai W. The effects of different lipid emulsions on the lipid profile, fatty acid composition, and antioxidant capacity of preterm infants: A double-blind, randomized clinical trial. Clin Nutr. 2016 Oct;35(5):1023-31. doi: 10.1016/j.clnu.2015.10.011. Epub 2015 Oct 31.
PubMed 26561301
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants
- ClinicalTrials.gov ID
- NCT01683162
- Acronym / sponsor ID
- PNDLEIPI
- Conditions
- Preterm Infant
- Keywords
- parenteral nutrition, lipid emulsion, olive oil, liver function, fatty acid, clinical outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wei CaiUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in preterm infants, a showed efficacy and a good clinical and biological safety profile. The objective of this study was to assess the effects of a new olive-oil based lipid emulsion compared with the traditional lipid emulsions.
Detailed description
For a number of years, lipid emulsions have been used in the nutritional support of surgical and critically ill patients, with the aim of supplying substrates to meet energy demands and providing building blocks for wound healing and tissue repair. Two types of lipid emulsions are currently used for adult as well as pediatric patients: one lipid emulsions prepared from soybean oil that are composed of long-chain triacylglycerols (LCTs), 62% of which are polyunsaturated fatty acids (PUFAs), and the other lipid emulsions composed of 50% medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion (20%) of PUFAs and 60% monounsaturated fatty acids (MUFAs). There are so many investigations with olive oil-based emulsion including in-vitro studies, animal studies, and infusion studies in healthy subjects and in various patient groups. In-vitro and animal studies demonstrate that the impairment of immune function, especially of T cell responses, that occurs with soybean oil-based emulsions is avoided with ClinOleic. Studies in infants and adults have consistently shown that olive oil-based emulsion increases the oleic acid content of blood lipids and that it avoids the depletion of long chain n-6 PUFA derivatives of linoleic acid that is seen with soybean oil-based emulsion. The less unsaturated nature of olive oil-based emulsion compared will possibly decrease oxidative stress. Further studies are required to test their beneficial effect from olive oil consumption in preterm infants.
The investigators designed a double-blind, randomized clinical trial to performed the effect of lipometabolism, oxidative stress and clinical outcomes of olive oil , MCY/LCT and LCT lipid emulsions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olive oil lipid emulsion | Experimental | Drug: ClinOleicthe olive oil lipid emulsion is ClinOleic |
| MCT/LCT lipid emulsion | Experimental | Drug: Lipofundinthe MCT/LCT lipid emulsion is Lipofundin |
| LCT lipid emulsion | Experimental | Drug: Intralipidthe LCT lipid emulsion is Intralipid |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Infants of both genders
- Hospitalized
- The parent of the infant agreed to participate by signing an informed consent form
- Infants admitted hospital within 72 hours after birth(gestational age<37 weeks)
- Birth weight <= 2000g
Key exclusion criteria (11 listed)
- Receiving PN before screening
- EN caloric>10%
- Obstruction jaundice
- Suspected or identified biliary tract atresia
- Neonatal hepatitis
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 |
|---|---|---|
| ClinOleicthe lipid of all-in-one, 0.5-3.5g/kg.d | Drug | Olive oil lipid emulsion |
| Lipofundinthe lipid of all-in-one, 0.5-3.5g/kg.d | Drug | MCT/LCT lipid emulsion |
| Intralipidthe lipid of all-in-one, 0.5-3.5g/kg.d | Drug | LCT lipid emulsion |
Primary outcome
lipometabolism
Time frame: Change from Baseline in fatty acid at 7 days and 14 days
fatty acid
1 secondary outcome
oxidative stress
Time frame: Change from Baseline in liver function at 7 days and 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
- Derived from this study: PubMed 26561301Wang Y, Feng Y, Lu LN, Wang WP, He ZJ, Xie LJ, Hong L, Tang QY, Cai W. The effects of different lipid emulsions on the lipid profile, fatty acid composition, and antioxidant capacity of preterm infants: A double-blind, randomized clinical trial. Clin Nutr. 2016 Oct;35(5):1023-31. doi: 10.1016/j.clnu.2015.10.011. Epub 2015 Oct 31.
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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.
Wei Cai, Phd contact
Ying Wang, phd principal investigator
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ClinOleic, Lipofundin and Intralipid in people with Preterm Infant, run by Wei Cai at 1 site in China.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Wang, Phd (8613611884226, wangying_ssmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipometabolism (time frame: Change from Baseline in fatty acid at 7 days and 14 days). 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 NCT01683162, which also lists 1 linked publication.
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 18 Sep 2012.