Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Feeding and Eating Disorders of Childhood, Disorder of Stomach Function and Feeding Problems in Newborn

Intervention / Treatment
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* Drug: a control group
* Drug: a probiotic-supplemented group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm with birth weight <2.5kg Exclusion Criteria: Gastrointestinal bleeding and NEC,Kidney,liver function abnormal and have Serious congenital malformation

Ages Eligible for Study
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Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a control group<br>a control group : the same dose of luke warm water | Drug: a control group<br>* the same dose of luke warm water<br>|
| Experimental: treatment group<br>treatment group: viable Bifidobacterium 0.5 bid po | Drug: a probiotic-supplemented group<br>* was orally administered starting from day 2 after birth, at a dose of 0.5g (the numbers of Long Bifidobacterium, Lactobacillus acidophilus and Enterococcus faecalis in live>0.5*107CFU), twice per day, for 2 weeks<br>* Other names: the experimental group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal flora | measure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants | up to one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding intolerance | compare the feeding intolerance rate of three groups | up to one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm;, Intestinal flora;, early Micro-feeding, Feeding intolerance