A Mixed Lipid Emulsion for Prevention of Parenteral Nutrition Associated Cholestasis in Extremely Low Birth Weight Infants: A Randomized Clinical Trial.

Published on Dec 18, 2017in The Journal of Pediatrics4.406
· DOI :10.1016/J.JPEDS.2017.11.012
Andreas Repa18
Estimated H-index: 18
(Medical University of Vienna),
Christoph J. Binder67
Estimated H-index: 67
(Medical University of Vienna)
+ 5 AuthorsNadja Haiden18
Estimated H-index: 18
(Medical University of Vienna)
Sources
Abstract
Objectives To examine whether a mixed lipid emulsion reduces the incidence of parenteral nutrition associated cholestasis (PNAC) in extremely low birth weight (ELBW, Study design This double-blind randomized trial of 230 ELBW infants (June 2012-October 2015) was performed at a single level IV neonatal intensive care unit. Patients received either a mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil-(intervention) or a soybean oil-based lipid emulsion (control) for parenteral nutrition. The primary outcome measure was PNAC (conjugated bilirubin >1.5 mg/dL [25 µmol/L] at 2 consecutive measurements). The study was powered to detect a reduction of PNAC from 25% to 10%. Results Reasons for noneligibility of 274 infants screened were refusal to participate (n = 16), death (n = 10), withdrawal of treatment (n = 5), higher order multiples (n = 9), and parents not available for consent (n = 4). Intention to treat analysis was carried out in 223 infants (7 infants excluded after randomization). Parenteral nutrition associated cholestasis was 11 of 110 (10.1%) in the intervention and 18 of 113 (15.9%) in the control group (P = .20). Multivariable analyses showed no statistically significant difference in the intention to treat (aOR 0.428, 95% CI 0.155-1.187; P = .10) or per protocol population (aOR 0.457, 95% CI 0.155-1.347; P = .16). There was no statistically significant effect on any other neonatal morbidity. Conclusions The incidence of parenteral nutrition associated cholestasis was not significantly reduced using a mixed lipid emulsion in ELBW infants. Trial Registration ClinicalTrials.gov NCT01585935 .
Download
📖 Papers frequently viewed together
References48
Newest
Background: To examine whether SMOFlipid prevents progression of intestinal failure–associated liver disease (IFALD) in parenteral nutrition (PN)–dependent infants with early IFALD (conjugated bilirubin 17–50 µmol/L, 1-3 mg/dL). Study Design: Pilot multicenter blinded randomized controlled trial comparing SMOFlipid with Intralipid. Patients received the trial lipid for up to 12 weeks, unless they achieved full enteral tolerance sooner. The primary clinical outcome was the serum conjugated biliru...
Source
#1Carmel T Collins (University of Adelaide)H-Index: 23
#2Maria Makrides (University of Adelaide)H-Index: 70
Last. Robert A. GibsonH-Index: 80
view all 24 authors...
BackgroundStudies in animals and in humans have suggested that docosahexaenoic acid (DHA), an n−3 long-chain polyunsaturated fatty acid, might reduce the risk of bronchopulmonary dysplasia, but appropriately designed trials are lacking. MethodsWe randomly assigned 1273 infants born before 29 weeks of gestation (stratified according to sex, gestational age [<27 weeks or 27 to <29 weeks], and center) within 3 days after their first enteral feeding to receive either an enteral emulsion providing DH...
Source
#1Sakeer Vayalthrikkovil (U of C: University of Calgary)H-Index: 5
#2Rani A. Bashir (U of C: University of Calgary)H-Index: 6
Last. Abhay LodhaH-Index: 8
view all 7 authors...
Objective Omega-3 fatty acids are vital for brain and retinal maturation. It is not clear if early use of ω-3 fatty acids in the form of fish-oil lipid emulsions (FLEs) prevents retinopathy of prematurity (ROP) in preterm infants. The aim of this meta-analysis is to evaluate whether early administration of parenteral FLEs reduces ROP requiring laser therapy or severe ROP ≥stage 3 in preterm infants. Methods A literature search was performed to identify studies comparing parenteral FLEs with soyb...
Source
#1Ann Biesboer (CUW: Concordia University Wisconsin)H-Index: 3
#2Nancy A. Stoehr (CUW: Concordia University Wisconsin)H-Index: 1
Soybean oil–based intravenous fat emulsions have long been used as the primary product for delivery of lipid-based calories in parenteral nutrition formulations in the United States. Proinflammatory properties of these products may be related with poor clinical outcomes and have led investigators to develop newer generations of intravenous fat emulsions. These alternative formulations are derivatives of medium-chain triglycerides, olive oil, and fish oil in hopes to reduce the inflammatory respo...
Source
#1Andreas Repa (Medical University of Vienna)H-Index: 18
#2Ruth Lochmann (Medical University of Vienna)H-Index: 1
Last. Nadja Haiden (Medical University of Vienna)H-Index: 18
view all 6 authors...
Background. Parenteral nutrition associated cholestasis (PNAC) is a frequently observed pathology in extremely low birth weight (ELBW) infants. Its pathogenesis is determined by the composition and duration of parenteral nutrition (PN) as well as the tolerance of enteral feeds (EF). ‘‘Aggressive’’ nutrition is increasingly used in ELBW infants to improve postnatal growth. Little is known about the effect of ‘‘aggressive’’ nutrition on the incidence of PNAC. We analyzed the influence of implement...
Source
#1Alan H. Jobe (Cincinnati Children's Hospital Medical Center)H-Index: 101
Although bronchopulmonary dysplasia (BPD) is the most frequent adverse outcome for infants born at
Source
#1Kenneth Ng (BCM: Baylor College of Medicine)H-Index: 6
#2Barbara Stoll (ARS: Agricultural Research Service)H-Index: 46
Last. Douglas G. Burrin (BCM: Baylor College of Medicine)H-Index: 71
view all 11 authors...
Introduction: Parenteral nutrition (PN) in preterm infants leads to PN-associated liver disease (PNALD). PNALD has been linked to serum accumulation of phytosterols that are abundant in plant oil but absent in fish oil emulsions. Hypothesis: Whether modifying the phytosterol and vitamin E composition of soy and fish oil lipid emulsions affects development of PNALD in preterm pigs. Methods: We measured markers of PNALD in preterm pigs that received 14 days of PN that included 1 of the following: ...
Source
#1Iva HojsakH-Index: 32
#2Virginie ColombH-Index: 43
Last. Mary Fewtrell (ICH: UCL Institute of Child Health)H-Index: 71
view all 15 authors...
The aim of the present article was to perform a systematic review with meta-analysis of available scientific evidence regarding the role of different intravenous lipid emulsions (ILE) in the pathogenesis of cholestasis and parenteral nutrition-associated liver disease. A systematic review of the literature (up to March 2015) identified 23 randomized controlled trials (RCTs). Of these, 17 were performed in preterm infants or critically ill neonates with a short duration of intervention, 2 in olde...
Source
#1Vishal Kapoor (Redland Hospital)H-Index: 1
#2Rebecca Glover (Boston Children's Hospital)H-Index: 2
Last. Manoj N MalviyaH-Index: 4
view all 3 authors...
Background The pure soybean oil based lipid emulsions (S-LE) conventionally used for parenteral nutrition (PN) in preterm infants have high polyunsaturated fatty acid (PUFA) content. The newer lipid emulsions (LE) from alternative lipid sources with reduced PUFA content may improve clinical outcomes in preterm infants. Objectives To determine the safety and efficacy of the newer alternative LE compared with the conventional S-LE for PN in preterm infants. Search methods We used the standard sear...
Source
#1Amish Jain (U of T: University of Toronto)H-Index: 23
#2Prakesh S. Shah (U of T: University of Toronto)H-Index: 70
Patent ductus arteriosus (PDA) poses a diagnostic and therapeutic dilemma for clinicians. Diagnosis of persistent PDA and determination of its clinical and hemodynamic significance are challenging. Although the condition has been associated with substantial neonatal morbidities such as intraventricular hemorrhage, bronchopulmonary dysplasia, and necrotizing enterocolitis, most therapeutic approaches have failed to show improvement in these outcomes. As such, clinicians have tended toward conserv...
Source
Cited By25
Newest
#1M. Petrea Cober (Boston Children's Hospital)H-Index: 6
#2Kathleen M. Gura (Boston Children's Hospital)H-Index: 39
Last. Steven W. PlogstedH-Index: 5
view all 7 authors...
Lipid injectable emulsions (ILEs) are complex pharmaceutical formulations intended as a source of energy and fatty acids for parenteral nutrition (PN) therapy. Part 1 of this series addressed issues associated with and safety recommendations pertaining to adult ILE use. Part 2 addresses ILE safety in neonatal and pediatric patients. Considerations for ILE use in the neonatal and pediatric populations differ from those of adults. For example, these patients often require higher doses compared wit...
Source
#1Susannah FrancoH-Index: 1
#2Pavel Goriacko (Montefiore Medical Center)H-Index: 3
Last. Toshiba Morgan-Joseph (Montefiore Medical Center)H-Index: 1
view all 4 authors...
Background Parenteral nutrition (PN) is crucial for the improvement of long-term outcomes in very low birth weight (VLBW) neonates. Lipid injectable emulsions are a key component of PN, as they contain essential fatty acids and provide energy critical for brain growth. Prolonged administration increases risk of intestinal failure-associated liver disease, including cholestasis, and other complications. Methods This is a retrospective, quasi-experimental cohort study of 215 VLBW neonates. The pri...
Source
Premature neonates are submitted to an early-life oxidative stress from parenteral nutrition, which is vitamin C (VC) deficient and induces low endogenous levels of glutathione. The oxidative stress caused by these deficiencies may permanently affect liver glycolysis and lipogenesis. This study evaluates the short- and long-term effects of neonatal VC and cysteine deficient diets on redox and energy metabolism. Three-day-old Hartley guinea pigs from both sexes were given a regular or a deficient...
Source
#1Yi-Ling Wang (Boston Children's Hospital)
#2Lih-Ju Chen (CSMU: Chung Shan Medical University)
Last. Chien-Chou Hsiao (CSMU: Chung Shan Medical University)H-Index: 2
view all 6 authors...
ObjectivePreterm infants receive long-term parenteral nutrition (PN) for gastrointestinal immaturity. This study aimed to determine if mixed lipid emulsions containing fish oil decrease the inciden...
Source
#1Chiara Biagetti (Boston Children's Hospital)H-Index: 7
#2Alessio Correani (Boston Children's Hospital)H-Index: 7
Last. Virgilio P. Carnielli (Boston Children's Hospital)H-Index: 40
view all 10 authors...
Summary Background and aims Preterm infants are at increased risk of long-term neurodevelopmental disabilities (NDD). Long chain n-3 fatty acids play a key role during the development of the central nervous system and some studies in preterm infants showed benefits of docosahexaenoic acid and arachidonic acid supplementation for visual and cognitive development. In recent years fish oil has been added to the fat blend of intravenous (IV) lipid emulsions (LE) but to date scanty data are available...
Source
#1Jordan D. Secor (Boston Children's Hospital)H-Index: 2
#2Lumeng Yu (Boston Children's Hospital)
Last. Kathleen M. Gura (Boston Children's Hospital)H-Index: 39
view all 6 authors...
Introduction: Intestinal failure-associated liver disease (IFALD) refers to hepatic dysfunction that results from prolonged parenteral nutrition (PN) use. IFALD is multifactorial in origin and rema...
Source
#1Bram P. RaphaelH-Index: 12
#2Paul MitchellH-Index: 54
Last. Mark Puder (Boston Children's Hospital)H-Index: 53
view all 5 authors...
BACKGROUND Composite lipid emulsion (CLE) composed of soybean oil, medium-chain triglycerides, olive oil, and fish oil is approved in the US for parenterally fed adults. For stable children discharged on home parenteral nutrition (HPN) without cholestasis (direct bilirubin > 2.0 mg/dL), CLE has theoretical benefits over soybean-based intravenous lipid emulsion due to reduced phytosterol exposure with higher calorie support to permit reduced glucose infusion rates (GIRs), omega-3 supplementation,...
Source
#1Gregory Guthrie (BCM: Baylor College of Medicine)H-Index: 6
#2Douglas G. Burrin (BCM: Baylor College of Medicine)H-Index: 71
Total parenteral nutrition (TPN) is a life-saving intervention for infants that are unable to feed by mouth. Infants that remain on TPN for extended periods of time are at risk for the development of liver injury in the form of parenteral nutrition associated cholestasis (PNAC). Current research suggests the lipid component of TPN is a factor in the development of PNAC. Most notably, the fatty acid composition, vitamin E concentration, and presence of phytosterols are believed key mediators of l...
Source
#1Dalton K Hudgins (Novant Health)
#2Amy P Holmes (Boston Children's Hospital)
Last. J Brock Harris (Wingate University)
view all 4 authors...
PURPOSE Results of a study comparing the safety and efficacy outcomes with use of a soybean oil-based injectable lipid emulsion (SO-ILE) vs a 4-oil alternative product in a neonatal population are presented. METHODS In an institutional review board-approved, multicenter retrospective review, the medical records of 328 patients who were born at a gestational age of ≤34 weeks, had a birth weight of 500 to 2,000 g, were admitted to one of 2 neonatal intensive care units (NICUs) within a large healt...
Source
#1Jemma Cleminson (RVI: Royal Victoria Infirmary)
#2William McGuire (Ebor: University of York)H-Index: 62
Last. Nicholas D. Embleton (RVI: Royal Victoria Infirmary)H-Index: 57
view all 3 authors...
Source
This website uses cookies.
We use cookies to improve your online experience. By continuing to use our website we assume you agree to the placement of these cookies.
To learn more, you can find in our Privacy Policy.