Clinical Trial: Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase 2 Study of Oral Probiotics Reduce the Incidence and Severity of Necrotizing Enterocolitis for Very Low Birth Weight Infants -Multi-Center Randomized Control Trial

Brief Summary: We investigate the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective, masked, multi-center randomized control trial will be conducted level III neonatal center to evaluate the beneficial effects of probiotics for NEC among VLBW (<1500 g) infants. VLBW infants who start to feed enterally are eligible and are randomized into 2 groups after parental informed consents were obtained. Infants in the study group are fed with Infloran (Lactobacillus acidophilus and Bifidobacterium bifidus) with breast or formula milk twice daily for 6 weeks. Infants in the control group are fed with breast or formula milk alone. The clinicians caring for the infants are blinded to the group assignment. The primary outcome measurement is death or NEC (≧stage 2).

Detailed Summary:

Introduction NEC is a worldwide problem in preterm very low birth weight (VLBW) infants with highly variable incidence affecting 2.6% to 28% of these infants; 1.2.Recent reports suggest increasing occurrence of NEC, estimating up to 9000 cases of NEC in the United States every year, with death occurring in 20 % to 40% of affected individuals. [1.3] As the number of very low-birth-weight infants increases, NEC remains a critical eminent problem. 3[4] The pathogenesis of NEC is unknown, but is widely considered as a multi-factorial disease; prematurity, enteral feeding, intestinal hypoxia-ischemia, and bacterial colonization are considered major risk factors. [4] Researches showed that proinflammatory cytokines, such as interleukin-1.6.8. (IL-1, IL-6, IL-8) and tumor necrosis factor- (TNF- ) 5-711-13 and anti-inflammatory cytokines such as IL-10 and transforming growth factor- (TGF- ) 8-1014-16 by intestinal epithelial cells is highly relevant to be involved in the final common pathway of pathogen of NEC.5-10 11-16.In mature bowel, the intestinal environment is capable of producing an array of cytokines important in the development and control of inflammatory responses11 8. In contrast, the immaturity of the neonatal intestinal immune system is evidenced by decreased numbers of immune cells 12.13 9.10. Recently, it has bee thought that inappropriate, accentuated inflammatory response to colonizing pathogenic flora at premature gut plays a major role, the inflammatory cascade further promotes spread of bacteria or toxin, and end up with ischemia, necrosis and even perforation. 14-1617.18.19 We and Bin-Nun had proved that probitics reduces the incidence and severity of necrotizing enterocolitis in preterm VLBW infants. 17.18 Nevertheless, there is no solid data in the literature as to the optima strains, timing, dosage and duration of probiotics administering to preterm VLBW infants at preset; and these need further investig
Sponsor: China Medical University Hospital

Current Primary Outcome: The primary outcome measurement was death or NEC (≧stage 2) [ Time Frame: From April 1, 2005 to May 30, 2007 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary outcome were culture proved sepsis, chronic lung disease, periventricular leukomalacia (PVL) , weight gain per week, duration of TPN, lengthy of stay, cost effective analysis. [ Time Frame: From April 1, 2005 to May 30, 2007, ]

Original Secondary Outcome: Same as current

Information By: China Medical University Hospital

Dates:
Date Received: October 3, 2007
Date Started: February 2005
Date Completion:
Last Updated: October 4, 2007
Last Verified: October 2007