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Preventing Cholestasis Using SMOFLipid®

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585935
First Posted: April 26, 2012
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nadja Haiden,MD, Medical University of Vienna
  Purpose

Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for liver complications of PN, namely parenteral nutrition associated cholestasis (PNAC).

Intravenous lipid emulsions (ILE) based on soy bean oil are standard of care for provision of energy and essential fatty acids in preterm infants. However, they might be implicated in the pathogenesis of PNAC.

ILEs based on pure fish oil are proposed for therapy of PNAC. Recently a lipid emulsion containing 15 % fish oil together with soy bean, olive and MCT oil has become available in Europe (SMOFLIPID®). Such a balanced lipid emulsion might be more favourable than the standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore ILEs containing fish oil might exert a positive effect on neurodevelopment. However, there are no data so far.

The study aims to evaluate the fish oil containing ILE "SMOFlipid®" for its protective effect against PNAC in ELBW infants compared to standard treatment with the soy bean based ILE "Intralipid®". Furthermore neurodevelopment at 12 and 24 months of corrected gestational age will be investigated.


Condition Intervention Phase
Cholestasis Psychomotor Disorders, Developmental Drug: SMOFLIPID Drug: INTRALIPID Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Cholestasis in Premature Infants Using SMOFLipid®

Resource links provided by NLM:


Further study details as provided by Nadja Haiden,MD, Medical University of Vienna:

Primary Outcome Measures:
  • Incidence of parenteral nutrition associated cholestasis (PNAC) [ Time Frame: Participants will be followed for the duration of hospital stay (expected average 14 weeks) ]
    PNAC definition: Two consecutive conjugated bilirubin measurements > 1.5 mg/dl


Secondary Outcome Measures:
  • Bailey Scales of Infant Development III [ Time Frame: At 12 and 24 months corrected gestational age ]
    Cognitive, Motor and Language Development


Other Outcome Measures:
  • Brain maturational scores assessed by amplitude integrated EEG (aEEG) [ Time Frame: Participants will be followed for the duration of hospital stay (expected average 14 weeks) ]
    aEEG measurements of study infants performed as a part of clinical routine (as specified in the trial study protocol v 1.0-1.3)

  • Visual Evoced Potentials (VEP) [ Time Frame: Participants will be followed for the duration of hospital stay (expected average 14 weeks) ]
    VEP measurements of study infants performed as a part of clinical routine (as specified in the trial study protocol v 1.0-1.3)


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smoflipid
SMOFLIPID will be used for parenteral lipid supply
Drug: SMOFLIPID
target dose: 3g/kg/d
Other Name: SMOFLIPID (mixture of soy, fish, MCT and olive oil)
Active Comparator: Intralipid
INTRALIPID will be used for parenteral lipid supply
Drug: INTRALIPID
target dose: 3g/kg/d
Other Name: INTRALIPID (soy bean oil)

Detailed Description:

BACKGROUND: Extreme low birth weight infants (ELBW, < 1000 gram birth weight) are typically dependent on parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for development of liver complications of PN, namely parenteral nutrition associated cholestasis (PNAC).

Intravenous lipid emulsion (ILE) based on soy bean oil are standard of care in preterm infants, but might be implicated in the pathogenesis of PNAC. Fish oil is rich in omega-3 long chain polyunsaturated fatty acids (LC-PUFA) that particularly accumulate in liver and brain of the fetus during the last trimester of pregnancy. In pediatric patients, ILEs based on pure fish oil are proposed as a rescue therapy of PNAC.

Recently a mixed lipid emulsion containing 15 % fish oil together with soy bean , olive and MCT oil has become available for PN in Europe. Such a balanced lipid emulsion might be more favourable than the standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore ILEs containing fish oil might exert a positive effect on neurodevelopment. However there are no data so far.

AIM: To evaluate a fish oil containing ILE (SMOFlipid®) for its prophylactic effect on PNAC in ELBW infants compared to a soy bean based ILE (Intralipid®).

STUDY DESIGN: Double blind prospective randomized trial.

  • Primary Outcome: PNAC defined as two conjugated bilirubin > 1.5 mg/dl measurements on two consecutive occasions.
  • Secondary Outcome: The most important secondary outcome is neurodevelopment at 12 and 24 months of corrected age.
  • Exploratory Outcomes: Brain maturation measured by amplitude integrated EEG (aEEG) and flashed visual evoked potentials as available from clinical routine examinations

HYPOTHESIS: The use of a mixed lipid emulsion containing fish oil (SMOFLIPID®) will reduce the incidence of PNAC compared to a standard soy bean oil based lipid emulsion.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth weight ≤ 1000 Gram
  • Admission to the neonatal ward in the first 24 hours of life
  • Informed consent and randomization in the first 5 days of life

Exclusion Criteria:

  • Triplets or higher
  • Conjugated bilirubin > 1.5 mg/dl before inclusion to the study
  • Conditions associated with cholestasis independent of parenteral nutrition, i.e. inborn errors of metabolism, viral infections (cytomegaly virus, HIV, Hep B, Hep C), immune mediated hemolytic disease (Rhesus incompatibility), cystic fibrosis and any other primary cholestatic disease
  • Congenital neurological malformations for secondary outcome
  Contacts and Locations
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): NCT01585935


Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Director: Andreas Repa, MD Medical University Vienna
Principal Investigator: Nadja Haiden, MD Medical University Vienna
  More Information

Additional Information:
Responsible Party: Nadja Haiden,MD, Assoc.Prof.MD., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01585935     History of Changes
Other Study ID Numbers: MUV-Neo2
2011-005456-33 ( EudraCT Number )
First Submitted: April 16, 2012
First Posted: April 26, 2012
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of the trial, we currently plan to share IPD upon personal request.
Supporting Materials: Study Protocol
Time Frame: After publication for 10 years.
Access Criteria: We are planning to publish the protocols together with the statistical analysis plan as supplemental information. This however depends on the respective journal. Otherwise please request the study protocol together with the statistical analysis plan from the study director andreas.repa@meduniwien.ac.at

Keywords provided by Nadja Haiden,MD, Medical University of Vienna:
Infant, Extremely Low Birth Weight
Parenteral Nutrition
Fish Oils
Cholestasis
Psychomotor Disorders, Developmental

Additional relevant MeSH terms:
Cholestasis
Psychomotor Disorders
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions