Preventing Cholestasis Using SMOFLipid®
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| ClinicalTrials.gov Identifier: NCT01585935 |
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Recruitment Status :
Completed
First Posted : April 26, 2012
Last Update Posted : January 9, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Cholestasis Psychomotor Disorders, Developmental | Drug: SMOFLIPID Drug: INTRALIPID | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Preventing Cholestasis in Premature Infants Using SMOFLipid® |
| Study Start Date : | June 2012 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | November 13, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Smoflipid
SMOFLIPID will be used for parenteral lipid supply
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Drug: SMOFLIPID
target dose: 3g/kg/d
Other Name: SMOFLIPID (mixture of soy, fish, MCT and olive oil) |
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Active Comparator: Intralipid
INTRALIPID will be used for parenteral lipid supply
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Drug: INTRALIPID
target dose: 3g/kg/d
Other Name: INTRALIPID (soy bean oil) |
- 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
- Bailey Scales of Infant Development III [ Time Frame: At 12 and 24 months corrected gestational age ]Cognitive, Motor and Language Development
- 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 Evoked 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)
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| Ages Eligible for Study: | 1 Day to 5 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Austria | |
| Medical University Vienna | |
| Vienna, Austria, 1090 | |
| Study Director: | Andreas Repa, MD | Medical University Vienna | |
| Principal Investigator: | Nadja Haiden, MD | Medical University Vienna |
Documents provided by Nadja Haiden,MD, Medical University of Vienna:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nadja Haiden,MD, Assoc.Prof.MD., Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01585935 |
| Other Study ID Numbers: |
MUV-Neo2 2011-005456-33 ( EudraCT Number ) |
| First Posted: | April 26, 2012 Key Record Dates |
| Last Update Posted: | January 9, 2018 |
| Last Verified: | January 2018 |
| 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 |
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Infant, Extremely Low Birth Weight Parenteral Nutrition Fish Oils Cholestasis Psychomotor Disorders, Developmental |
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Cholestasis Psychomotor Disorders Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Soybean oil, phospholipid emulsion SMOFlipid Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |