The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis
Summary
Introduction and objectives: Lipid emulsions play an important role in parenteral nutrition in preterm infants. We aim to evaluate the effect of two different intravenous lipid emulsions on the outcomes of neonatal sepsis in preterm infants. Methods: A randomized controlled trial is conducted in the Neonatal Care Unit of Mansoura University Children's Hospital, Egypt. Forty preterm infants with clinically suspected sepsis are enrolled and assigned randomly into one of two groups, one receive MOFS lipid emulsion (MOFS group) and the other receive pure soyabean oil-based emulsion (S group). Clinical and epidemiological data are collected. Assessment is done on 1st day and 7th day post randomization including growth parameters, complete blood count, C-reactive protein, random blood glucose, serum creatinine, serum triglyceride, soluble intercellular adhesion molecule 1 (sICAM-1) and leukocyte integrin β2. Between-groups and within-group differences will be analyzed statistically.
Timeline
- Start
- 2016-02-01
- Primary completion
- 2017-01-02
- Completion
- 2017-02-01
Publications
- Results Paolucci M, Landini MP, Sambri V. How can the microbiologist help in diagnosing neonatal sepsis? Int J Pediatr. 2012;2012:120139. doi: 10.1155/2012/120139. Epub 2012 Jan 26.
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- Results Ramel SE, Brown LD, Georgieff MK. The Impact of Neonatal Illness on Nutritional Requirements-One Size Does Not Fit All. Curr Pediatr Rep. 2014 Dec;2(4):248-254. doi: 10.1007/s40124-014-0059-3.
- Results Christmann V, Visser R, Engelkes M, de Grauw AM, van Goudoever JB, van Heijst AF. The enigma to achieve normal postnatal growth in preterm infants--using parenteral or enteral nutrition? Acta Paediatr. 2013 May;102(5):471-9. doi: 10.1111/apa.12188. Epub 2013 Feb 25.
- Results Kapoor V, Glover R, Malviya MN. Alternative lipid emulsions versus pure soy oil based lipid emulsions for parenterally fed preterm infants. Cochrane Database Syst Rev. 2015 Dec 2;2015(12):CD009172. doi: 10.1002/14651858.CD009172.pub2.
- Results de Meijer VE, Gura KM, Le HD, Meisel JA, Puder M. Fish oil-based lipid emulsions prevent and reverse parenteral nutrition-associated liver disease: the Boston experience. JPEN J Parenter Enteral Nutr. 2009 Sep-Oct;33(5):541-7. doi: 10.1177/0148607109332773. Epub 2009 Jul 1.
- Results Koletzko B, Goulet O. Fish oil containing intravenous lipid emulsions in parenteral nutrition-associated cholestatic liver disease. Curr Opin Clin Nutr Metab Care. 2010 May;13(3):321-6. doi: 10.1097/MCO.0b013e3283385407.
- Results Resch B, Gusenleitner W, Muller WD. Procalcitonin and interleukin-6 in the diagnosis of early-onset sepsis of the neonate. Acta Paediatr. 2003;92(2):243-5. doi: 10.1111/j.1651-2227.2003.tb00534.x.
- Results Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R; Parenteral Nutrition Guidelines Working Group; European Society for Clinical Nutrition and Metabolism; European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN); European Society of Paediatric Research (ESPR). 1. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the European Society of Paediatric Research (ESPR). J Pediatr Gastroenterol Nutr. 2005 Nov;41 Suppl 2:S1-87. doi: 10.1097/01.mpg.0000181841.07090.f4. No abstract available.
- Results Al-Taiar A, Hammoud MS, Cuiqing L, Lee JK, Lui KM, Nakwan N, Isaacs D. Neonatal infections in China, Malaysia, Hong Kong and Thailand. Arch Dis Child Fetal Neonatal Ed. 2013 May;98(3):F249-55. doi: 10.1136/archdischild-2012-301767. Epub 2012 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | SMOFlipid | Other / unclassified | 3.5 g/kg | — |