A Mixed Lipid Emulsion for Prevention of Parenteral Nutrition Associated Cholestasis in Extremely Low Birth Weight Infants: A Randomized Clinical Trial - 23/02/18
, Christoph Binder, MD 1, Margarita Thanhaeuser, MD 1, Alexandra Kreissl, PhD 1, Eleonore Pablik, Boecc 2, Mercedes Huber-Dangl, MD 1, Angelika Berger, MD, MBA 1, Nadja Haiden, MD 1Abstract |
Objectives |
To examine whether a mixed lipid emulsion reduces the incidence of parenteral nutrition associated cholestasis (PNAC) in extremely low birth weight (ELBW, <1000 g) infants.
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.
Le texte complet de cet article est disponible en PDF.Keywords : soy bean oil, retinopathy of prematurity, bronchopulmonary dysplasia
Abbreviations : BPD, DHA, EFA, ELBW, ITT, LC-PUFA, MCT, NEC, PMA, PN, PNAC, RCT, ROP, SMOF-LE
Plan
| Funded by the Austrian Science Fund (FWF, KLI99-B00). Study lipids were supplied free of charge by Herba Chemosan (Graz, Austria). |
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| A.R. received funding from Fresenius Kabi (Graz, Austria) to employ a clinical research nurse The other authors declare no conflicts of interest. |
Vol 194
P. 87 - mars 2018 Retour au numéro
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