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ROLE OF PROBIOTICS IN PREVENTION OF NECROTIZING ENTEROCOLITIS DR. ZAHRA A. SYEDA, MSC REPRODUCTION AND DEVELOPMENT, UNIVERSITY OF BRISTOL, BRISTOL, UKINTRODUCTION: Necrotizing enterocolitis is a challenging disease 125mg/kg mixed in milk twice daily in addition to the breast milk for a period • PARTICIPANT INFORMATION SHEETforthe neonatologists all over the world, affecting up to 28% of premature of 6 weeks. The criteria for selection in the study will be the premature • PARENTAL CONSENT FORMinfants. The most puzzling feature of the disease is its unknown cause and infants which are free from other infections, diseases and congenital • NEW MEDICAL PRODUCT FORMnon-availability of specific treatment. The diagnosis is apprehended anomalies. Mothers should be free from any disease such as gestational diabetes, preeclampsia etc. Statistical analysis, chi square test will be • RESEARCH ETHICS COMMITTEE APPLICATION FORMclinically and management is usually supportive. Several factors howevermay contribute to the pathogenesis of the disease including applied to compare the efficacy of the treatment in study and controlprematurity, intestinal ischemia, oral feedings and lack of intestinal flora. groups. Relative Risk will be calculated. The severity of the disease will beInterestingly the rate is found to be significantly lower in breast fed infants judged according to Bell’s criteria.in comparison to the formula fed babies probably due to the Probioticsnaturally available in the human milk. Bell’s staging criteria • Stage I (suspected NEC) • Stage II (definite NEC) • Stage III (advanced NEC, severely ill) • Stage IIIA (without perforation) • Stage IIIB (with perforation) RESOURCE COSTING Premature with NEC Abdominal X-rays showing intestinal distension REFERENCES The total estimated cost of the research study is £ 27,000 which is justified as follows according to TRAC/ fEC Directly incurred costs:HYPOTHESIS : We hypothesize that oral Probiotics help prevention of Staff and Research costs - £ 11,000 divided as follows Principal 1. Alfaleh K, Bassler D. Probiotics for prevention of necrotizingNecrotizing Enterocolitis in premature infants. enterocolitis in preterm infants. Cochrane Database Syst Rev. 2008 researchers: One researcher on full time duty at 8 hours / week for 6 Jan 23;(1):CD005496 weeks. Total cost £ 3,000 Co researchers: One research assistant on full time duty at 8 hours/ week for 6 weeks. Total cost £ 3,000 Part time 2. Barclay AR, Stenson B, Simpson JH, Weaver LT, Wilson DC, Probiotics BACKGROUND: Probiotics are defined as dietary supplements for necrotizing enterocolitis: a systematic review. : J Pediatr Gastroenterolcontaining live microorganisms as bacteria or yeasts which are beneficial researchers: Two nursing assistants on part time duty at 4 hours/week for 6 weeks. Total cost £ 3,000 Computer personnel: One IT personnel on part Nutr. 2007 Nov; 45(5): 569-76.for the health of the host organisms. The most commonly used organisms 3. Moumita Samantaa, Mihir Sarkara, Promit Ghoshb, Jayanta krare strains of Lactobacillus and Bifidobacteria which are able to convert time duty at 4 hours/ week for 6 weeks. Total cost £ 1,000 Neonatologists: Two neonatologists for daily visits twice a day for 6 weeks. Total cost £ Ghosha, Malay kr Sinhaa and Sukanta Chatterjeea Prophylactic Probioticscarbohydrates and sugars into lactic acid, thus lowering the pH of the for Prevention of Necrotizing Enterocolitis in Very Low Birth Weightenvironment. Oral supplements of Probiotics also compete with the harmful 1,000microorganisms such as Klebsiella pneumoniae, Escherichia coli and Drug and Equipment costs - £ 10,500 for the following items Newborns. J Trop Pediatr. 2009 Apr;55(2):128-31.Candida albicans in the mucosal wall thus inhibiting their growth and • Probiotic capsules: Oral probiotic capsule cost of course of treatment 4. www.grs.wales.nhs.uk/instantkb13/FileRedirect.aspx?FileID=1103development, one of the main causes of Necrotizing enterocolitis and or six weeks is £ 80 per infant, which is £ 8,000 in total 100 infants in 5. Martin CR, Walker WA. Probiotics: role in pathophysiology andneonatal sepsis. study group. prevention in necrotizing enterocolitis. Semin Perinatol. 2008 Apr; • Breast milk from Milk bank for 100 infants will cost nearly £ 1,000 32(2):127-37.RESEARCH QUESTION AND AIMS OF THE • Bottles for feeding (Johnson and Johnson) £ 300 6. Hoyos AB. Reduced incidence of necrotizing enterocolitis associated • Sterilization equipments for bottles before feeding £ 100 with enteral administration of Lactobacillus acidophilus and BifidobacteriumPROJECT: The objective of the study is to test the role of prophylactic • Dresses and gloves aprons, shoe covers, caps and gloves for infantis to neonates in an intensive care unit. Int J Infect Dis. 1999probiotics as a natural defense in reducing the incidence and severity of Summer;3(4):197-202.necrotizing enterocolitis in premature infants less than 1500g birth weight. examination of the infant £100In recent small clinical trials it has been suggested that probiotic agents • Laboratory tests in case laboratory tests are required to confirmmight reduce the risk of Necrotizing enterocolitis in preterm infants which diagnosis £ 400needs to be evaluated at larger scale regarding the type of supplement to • Computer for data collection and analysis £ 500be used. • Electricity and power expenses £ 100 • Travel costs for return tickets - £ 3,500 Indirect Costs:PREVIOUS STUDY RESULTS: Previous studies showed oral • Research Facility items - £ 2,000Probiotic supplementation significantly reduced the risk of severe NEC (1) ETHICAL ISSUESSTUDY DESIGN: Infants in the study will be selected bycomputerized random number and blindly allocated into control group andstudy groups each arm 100 infants. The babies in the control group will be To cover ethical issues during the study the following forms are preparedfed only on the breast milk while the study group will be given Probiotics and filledcapsule supplements, namely Infloran 250mg, according to body weight