Bifidobacterium Supplementation for Very Low Birth Weight Infants

Study Overview
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Brief Summary
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Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.

Official Title
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Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants

Conditions
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Preterm Infants

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium bifidum supplementation
* Dietary Supplement: Placebo contains dextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants with birth weight less than 1500g Exclusion Criteria: Sever bacteremia Congenital anomaly Not suitable for the trial defined by an attending neonatologist

Ages Eligible for Study
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Maximum Age: 48 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 |
| --- | --- |
| Active Comparator: Active<br>Bifidobacterium bifidum | Dietary Supplement: Bifidobacterium bifidum supplementation<br>* Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day<br>* Other names: Bifidobacterium bifidum OLB6378;|
| Placebo Comparator: Placebo<br>Dextrin without Bifidobacterium bifidum | Dietary Supplement: Placebo contains dextrin<br>* 0.5 of dextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postnatal day when enteral feeding exceeded at 100ml/kg/day | Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint. | From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standard deviation(SD) scores of bodyweight(BW) and head circumference(HC) | BW gain/day, SD scores of BW and HC at discharge from NICU | For the duration of NICU stay, an expected average of 3 months | 
| Necrotizing enterocolitis or sepsis | The incidences of necrtizing enterocolitis or sepsis during the stay in NICU | For the duration of NICU stay, an expected average of 3 months | 
| Intestinal flora | Intestinal flora during the stay in NICU | For the duration of NICU stay, an expected average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, preterm infants, enteral feeding, Bifidobacterium on enteral feeding