Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infants requiring parenteral nutrition
Tomsits E, Pataki M, Tölgyesi A, Fekete G, Rischak K, Szollár L
Journal of pediatric gastroenterology and nutrition · 127 citas
Etiquetas de revisión
Alimentación controladaFinanciación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2010-06-05 · J Pediatr Gastroenterol Nutr · vol. 51 · número 4 · págs. 514–521
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 219 citas · más que el 98% de estudios similares · 10.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 46 trabajos
- Acceso
- De pago
- Áreas de investigación
- Infant Nutrition and Health · Clinical Nutrition and Gastroenterology · Neonatal skin health care
- Palabras clave
- Medicine, Fish oil, Soybean oil, Olive oil, Emulsion, Lipid emulsion, Double blind, Parenteral nutrition, Clinical trial, Fat emulsion, Food science, Medium-chain triglyceride, Fish <Actinopterygii>, Triglyceride, Surgery, Biochemistry, Internal medicine, Cholesterol, Fishery
- MeSH
- humans, body weight, weight gain, thinness, soybean oil, fat emulsions, intravenous, triglycerides, fish oils, plant oils, treatment outcome, parenteral nutrition, double-blind method, infant, newborn, infant, premature, infant nutritional physiological phenomena, olive oil
6 autores
- Erika Tomsits🇭🇺 · autor de correspondenciaSemmelweis University
- Margit Pataki🇭🇺 · autor de correspondenciaSemmelweis University
- Andrea Tölgyesi🇭🇺 · autor de correspondenciaSemmelweis University
- György Fekete🇭🇺 · autor de correspondenciaSemmelweis University
- Katalin Rischák🇭🇺Semmelweis University
- Lajos G. Szollár🇭🇺Semmelweis University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objectives
Safety, tolerability, and efficacy of a novel lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil (SMOFlipid 20%) with reduced n-6 fatty acids (FA), increased monounsaturated and n-3 FA, and enriched in vitamin E were evaluated in premature infants compared with a soybean oil-based emulsion.
Patients and methods
Sixty (30/30) premature neonates (age 3-7 days, gestational age ≤ 34 weeks, birth weights 1000-2500 g) received parenteral nutrition (PN) with either SMOFlipid 20% (study group) or a conventional lipid emulsion (Intralipid 20%, control group) for a minimum of 7 up to 14 days. Lipid supply started at 0.5 g · kg body weight(-1) · day(-1) on day 1 and increased stepwise (by 0.5 g) up to 2 g · kg body weight(-1) · day(-1) on days 4 to 14. Safety and efficacy parameters were assessed on days 0, 8, and 15 if PN was continued.
Results
Adverse events, serum triglycerides, vital signs, local tolerance, and clinical laboratory did not show noticeable group differences, confirming the safety of study treatment. At study end, γ-glutamyl transferase was lower in the study versus the control group (107.8 ± 81.7 vs 188.8 ± 176.7 IU/L, P < 0.05). The relative increase in body weight (day 8 vs baseline) was 5.0% ± 6.5% versus 5.1% ± 6.6% (study vs control, not significant). In the study group, an increase in n-3 FA in red blood cell phospholipids and n-3:n-6 FA ratio was observed. Plasma α-tocopherol (study vs control) was increased versus baseline on day 8 (26.35 ± 10.03 vs 3.67 ± 8.06 μmol/L, P < 0.05) and at study termination (26.97 ± 18.32 vs 8.73 ± 11.41 μmol/L, P < 0.05).
Conclusions
Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n-3 FA, and vitamin E status in premature infants requiring PN.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.