The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis

NCT03275090 | Completed Phase 4 DMC

• 1 other identifier: MansouraUCH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis Newborn

Keywords

lipid emulsions; preterm; sepsis

Outcome Measures

Primary Outcomes (2)

• levels of soluble intercellular adhesion molecule 1 (sICAM-1)

  changes in levels of sICAM-1 in septic preterm infants after receiving one of the two different lipid emulsions for seven days.

  "first day of randomization and 7th days"

• leukocyte integrin ß2 Level

  changes in leukocyte integrin ß2 level in septic preterm infants after receiving one of the two different lipid emulsions for seven days.

  "first day of randomization and 7th days"

Secondary Outcomes (4)

• duration of hospital stay

  "through study completion, an average of 12 months"

• Duration of antibiotic treatment

  "through study completion, an average of 12 months"

• Duration of mechanical ventilation

  "through study completion, an average of 12 months"

• Mortality rate

  "through study completion, an average of 12 months"

Study Arms (2)

Intralipid injectable product (MOFS)

ACTIVE COMPARATOR

20 preterm infants receive parenteral nutrition containing 20% MOFS lipid emulsion (Smoflipid ®)

Drug: Smoflipid ®

Pure Soybean oil lipid emulsion

NO INTERVENTION

20 preterm infants with sepsis receive the usual parenteral nutrition containing soybean oil based lipid emulsion (20% Intralipid ®) at daily increasing doses guided by serum triglycerides.

Interventions

Smoflipid ® DRUG

Also known as: MOFS lipid emulsion

Intralipid injectable product (MOFS)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age of 28 to less than 37 weeks who showed clinical symptoms and signs suggestive of early-onset sepsis (EOS, within 72 hours of birth) or late-onset sepsis (LOS, after 72 hours of birth) and received PN.

You may not qualify if:

• Major congenital malformations
• Congenital heart diseases
• Inborn errors of metabolism
• Congenital infections
• Hypoxic-ischemic encephalopathy

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (14)

• 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.

  PMID: 22319539 RESULT

• Mohsen L, Ramy N, Saied D, Akmal D, Salama N, Abdel Haleim MM, Aly H. Emerging antimicrobial resistance in early and late-onset neonatal sepsis. Antimicrob Resist Infect Control. 2017 Jun 13;6:63. doi: 10.1186/s13756-017-0225-9. eCollection 2017.

  PMID: 28630687 RESULT

• Shehab El-Din EM, El-Sokkary MM, Bassiouny MR, Hassan R. Epidemiology of Neonatal Sepsis and Implicated Pathogens: A Study from Egypt. Biomed Res Int. 2015;2015:509484. doi: 10.1155/2015/509484. Epub 2015 Jun 4.

  PMID: 26146621 RESULT

• Edgar JD, Gabriel V, Gallimore JR, McMillan SA, Grant J. A prospective study of the sensitivity, specificity and diagnostic performance of soluble intercellular adhesion molecule 1, highly sensitive C-reactive protein, soluble E-selectin and serum amyloid A in the diagnosis of neonatal infection. BMC Pediatr. 2010 Apr 16;10:22. doi: 10.1186/1471-2431-10-22.

  PMID: 20398379 RESULT

• Mishra UK, Jacobs SE, Doyle LW, Garland SM. Newer approaches to the diagnosis of early onset neonatal sepsis. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F208-12. doi: 10.1136/adc.2004.064188.

  PMID: 16632649 RESULT

• Turunen R, Andersson S, Nupponen I, Kautiainen H, Siitonen S, Repo H. Increased CD11b-density on circulating phagocytes as an early sign of late-onset sepsis in extremely low-birth-weight infants. Pediatr Res. 2005 Feb;57(2):270-5. doi: 10.1203/01.PDR.0000148717.59861.2C. Epub 2004 Dec 7.

  PMID: 15585684 RESULT

• 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.

  PMID: 25722954 RESULT

• 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.

  PMID: 23398476 RESULT

• 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.

  PMID: 26630252 RESULT

• 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.

  PMID: 19571170 RESULT

• 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.

  PMID: 20393276 RESULT

• 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.

  PMID: 12710654 RESULT

• 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.

  PMID: 16254497 RESULT

• 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.

  PMID: 22942104 RESULT

MeSH Terms

Conditions

Neonatal Sepsis; Premature Birth; Sepsis

Interventions

SMOFlipid

Condition Hierarchy (Ancestors)

Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Yahya M Wahba, MD

  Mansoura University Children Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 7, 2017
• Study Start: February 1, 2016
• Primary Completion: January 2, 2017
• Study Completion: February 1, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)