Preterm InfantsPhase 4NCT01786759
Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
A Phase 4 study testing ClinOleic and Intralipid in people with Preterm Infants, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative products available elsewhere.So we compare the different fat emulsion, and want to see if the… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Preterm Infants
- What is being tested?
- ClinOleic and Intralipid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Jul 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 28 days
- 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
- Enteral nutrition(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
- Cytomegaoviyns(CMV), virus hepatitis and syphilis infection
- Congenital or acquired immune deficiency
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua hospital
Shanghai, Shanghai Municipality, 200092
Yexuan Tao, PhD, 13818334664, taoyexuan@hotmail.cm
Wei Cai, PhD
About this study
The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative products available elsewhere.So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.
Read the detailed description
Parenteral nutrition (PN) has been widely and successfully used in the pediatric population for more than 40 years, the most serious and significant life-threatening complication today continues to be parenteral nutrition-associated cholestasis(PNAC). Parenteral nutrition-associated cholestasis is indeed the most worrisome complication because it is difficult to treat and may progress to eventual cirrhosis and liver failure namely parenteral nutrition-associated liver disease (PNALD).
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), 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 polyunsaturated fatty acids(PUFAs)and 60% monounsaturated fatty acids (MUFAs). So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.
- Conditions
- Preterm Infants
- Being tested
- ClinOleic, Intralipid
- Keywords
- lipids, preterm infants, parenteral nutrition, liver function
- Medical subject headings
- 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
IntralipidDrug
the lipid of all-in-one, 0.5-3.5g/kg.d
| Study group | Role | What they receive |
|---|---|---|
| LCT lipid emulsion | Active comparator | the LCT lipid emulsion is Intralipid Receives: Drug: ClinOleic; Drug: Intralipid |
| Olive oil lipid emulsion | Experimental | the olive oil lipid emulsion is ClinOleic Receives: Drug: ClinOleic; Drug: Intralipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver function
Total Bile Acid(TBA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(AKP),γ-glutamyl transpeptidase(GGT),total bilirubin(Tbi),Direct bilirubin(Dbi)
Measured: Change from Baseline in fatty acid at 7 days and 14 days
Secondary outcomes (1)
bile acid
cholic acid,deoxycholic acid,Chenodeoxycholic Acid,ursodeoxycholic acid,lithocholic acid,et al.
Measured: Change from Baseline in fatty acid 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 posted8 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Cai, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wei Cai, PhD, Study chair, Xin Hua Hospital of Zhejiang ProvinceYing Wang, PhD, Principal investigator, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786759
- Sponsor's protocol ID
- HFBA
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
- ClinicalTrials.gov ID
- NCT01786759
- Acronym / sponsor ID
- HFBA
- Conditions
- Preterm Infants
- Keywords
- lipids, preterm infants, parenteral nutrition, liver function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 8 Feb 2013 (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.
The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative products available elsewhere.So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.
Detailed description
Parenteral nutrition (PN) has been widely and successfully used in the pediatric population for more than 40 years, the most serious and significant life-threatening complication today continues to be parenteral nutrition-associated cholestasis(PNAC). Parenteral nutrition-associated cholestasis is indeed the most worrisome complication because it is difficult to treat and may progress to eventual cirrhosis and liver failure namely parenteral nutrition-associated liver disease (PNALD).
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), 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 polyunsaturated fatty acids(PUFAs)and 60% monounsaturated fatty acids (MUFAs). So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCT lipid emulsion | Active comparator | Drug: ClinOleic, Drug: Intralipidthe LCT lipid emulsion is Intralipid |
| Olive oil lipid emulsion | Experimental | Drug: ClinOleic, Drug: Intralipidthe olive oil lipid emulsion is ClinOleic |
Who may qualify
- Ages
- 1 day to 28 days
- 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
- Enteral nutrition(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 | LCT lipid emulsion, Olive oil lipid emulsion |
| Intralipidthe lipid of all-in-one, 0.5-3.5g/kg.d | Drug | LCT lipid emulsion, Olive oil lipid emulsion |
Primary outcome
liver function
Time frame: Change from Baseline in fatty acid at 7 days and 14 days
Total Bile Acid(TBA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(AKP),γ-glutamyl transpeptidase(GGT),total bilirubin(Tbi),Direct bilirubin(Dbi)
1 secondary outcome
bile acid
Time frame: Change from Baseline in fatty acid 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 8 Feb 2013.
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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 study chair
Xin Hua Hospital of Zhejiang Province
Ying Wang, PhD principal investigator
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University
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 and Intralipid in people with Preterm Infants, run by Shanghai Jiao Tong University School of Medicine 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 8 Feb 2013. 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?
liver function (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?
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 8 Feb 2013.