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Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion

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ClinicalTrials.gov Identifier: NCT01786759
Recruitment Status : Unknown
Verified February 2013 by Wei Cai, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : February 8, 2013
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wei Cai, Shanghai Jiao Tong University School of Medicine

Brief 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 olive oil lipid emulsions can improve hepatic tolerance in preterm infant.

Condition or disease Intervention/treatment Phase
Preterm Infants Drug: ClinOleic Drug: Intralipid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
Study Start Date : October 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : July 2013

Arm Intervention/treatment
Active Comparator: LCT lipid emulsion
the LCT lipid emulsion is Intralipid
Drug: ClinOleic
the lipid of all-in-one, 0.5-3.5g/kg.d

Drug: Intralipid
the lipid of all-in-one, 0.5-3.5g/kg.d

Experimental: Olive oil lipid emulsion
the olive oil lipid emulsion is ClinOleic
Drug: ClinOleic
the lipid of all-in-one, 0.5-3.5g/kg.d

Drug: Intralipid
the lipid of all-in-one, 0.5-3.5g/kg.d




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. bile acid [ Time Frame: Change from Baseline in fatty acid at 7 days and 14 days ]
    cholic acid,deoxycholic acid,Chenodeoxycholic Acid,ursodeoxycholic acid,lithocholic acid,et al.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786759


Contacts
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Contact: Ying Wang, PhD 8613611884226 wangying_ssmu@126.com

Locations
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China, Shanghai
Xinhua hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: Yexuan Tao, PhD    13818334664    taoyexuan@hotmail.cm   
Principal Investigator: Wei Cai, PhD         
Principal Investigator: Ying Wang, PhD         
Sub-Investigator: Kejun Zhou, PhD         
Sub-Investigator: Qingya Tang, MD         
Sub-Investigator: Lina Lu, PhD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Wei Cai, PhD Xin Hua Hospital
Principal Investigator: Ying Wang, PhD Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University

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Responsible Party: Wei Cai, vice-president, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01786759     History of Changes
Other Study ID Numbers: HFBA
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Keywords provided by Wei Cai, Shanghai Jiao Tong University School of Medicine:
lipids
preterm infants
parenteral nutrition
liver function
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Bile Acids and Salts
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Gastrointestinal Agents