NCT01683162

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

5 months

First QC Date

July 18, 2012

Last Update Submit

September 15, 2012

Conditions

Preterm Infant

Keywords

parenteral nutritionlipid emulsionolive oilliver functionfatty acidclinical outcomes

Outcome Measures

Primary Outcomes (1)

  • lipometabolism

    fatty acid

    Change from Baseline in fatty acid at 7 days and 14 days

Secondary Outcomes (1)

  • oxidative stress

    Change from Baseline in liver function at 7 days and 14 days

Other Outcomes (1)

  • clinical outcomes

    before PN; participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Study Arms (3)

Olive oil lipid emulsion

EXPERIMENTAL

the olive oil lipid emulsion is ClinOleic

Drug: ClinOleic

MCT/LCT lipid emulsion

EXPERIMENTAL

the MCT/LCT lipid emulsion is Lipofundin

Drug: Lipofundin

LCT lipid emulsion

EXPERIMENTAL

the LCT lipid emulsion is Intralipid

Drug: Intralipid

Interventions

ClinOleicDRUG

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

Olive oil lipid emulsion
LipofundinDRUG

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

MCT/LCT lipid emulsion
IntralipidDRUG

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

LCT lipid emulsion

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26561301DERIVED

MeSH Terms

Conditions

Premature BirthHyperphagia

Interventions

ClinOleicLipofundinsoybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ying Wang, phd

    Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai,China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Wang, Phd

CONTACT

8613611884226wangying_ssmu@126.com

Wei Cai, Phd

CONTACT

caiw204@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice-president

Study Record Dates

First Submitted

July 18, 2012

First Posted

September 11, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

CN(1)