Clinical Trial: Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Brief Summary: Gut of newborn preterm is sterile, immediately by the mother and the surrounding environment from microbial colonization. As the effects of diet, intestinal flora is rapidly changed. Preterm children significantly delay in the establishment of normal flora,during hospitalization because of no breastfeeding, use of antibiotics, enteral feeding delay, combat disease and other factors. In this study, hospitalized preterm children for the study, the prospective randomized double-blind controlled study, to find oral intestinal bifidobacteria and lactobacilli and bifidobacteria subspecies composition and distribution, and further show intestinal bacteria in premature children case group.

Detailed Summary:

Preterm infants are at high risk of deeding intolerance especially low birth weight infants, Whether oral triple viable Bifidobacterium and early Micro-feeding may improve the symptoms of feeding intolerance.

84 preterm infants BW(birth weight) less than 2.5kg,entered neonatal intensive care unit(NICU) less than 24 hours and meet the Inclusion Criteria of this study will be Randomly divided into three groups, control group、 treatment group1 (Triple viable Bifidobacterium 0.5g bid po)、treatment group2 （Triple viable Bifidobacterium 0.5g bid po and early micro-feeding）. treatment period for more than 1 week. For three groups, feeding symptoms,the traits and frequency of stool of 3 days,1 weeks,2 weeks.And the stool flora measured by PCR.


Sponsor: Wang Hua

Current Primary Outcome: Intestinal flora [ Time Frame: up to one week ]

measure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants


Original Primary Outcome: Same as current

Current Secondary Outcome: Feeding intolerance [ Time Frame: up to one week ]

compare the feeding intolerance rate of three groups


Original Secondary Outcome: Same as current

Information By: Kunshan First People's Hospital Affiliated to Jiangsu University

Dates:
Date Received: February 2, 2014
Date Started: January 2014
Date Completion:
Last Updated: September 4, 2016
Last Verified: January 2014