The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.

Detailed Description
-----------------
Patients separated into four groups using the sealed envelope method.

Official Title
-----------------
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Conditions
-----------------
Necrotizing Enterocolitis, Sepsis

Intervention / Treatment
-----------------
* Dietary Supplement: Bifidobacterium lactis
* Dietary Supplement: Bifidobacterium lactis plus İnülin
* Other: Maltodextrin
* Dietary Supplement: İnulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VLBW infants admitted to NICU at the first 7 days of life Exclusion Criteria: expected life lower than 7 days, babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.), severe asphyxia, severe congenital anomaly

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bifidobacterium lactis<br>5 billion Bifidobacterium lactis | Dietary Supplement: Bifidobacterium lactis plus İnülin<br>* 5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given<br>* Other names: 5 billion Bifidobacterium lactis plus 900 mg İnülin;Other: Maltodextrin<br>* Maltodextrin<br>Dietary Supplement: İnulin<br>* 900 mg inulin per day will be given<br>|
| Active Comparator: İnulin<br>900 mg İnulin per day will be given | Dietary Supplement: Bifidobacterium lactis<br>* 5 billion active Bifidobacterium lactis<br>Dietary Supplement: Bifidobacterium lactis plus İnülin<br>* 5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given<br>* Other names: 5 billion Bifidobacterium lactis plus 900 mg İnülin;Other: Maltodextrin<br>* Maltodextrin<br>|
| Placebo Comparator: Maltodextrin<br>Maltodextrin | Dietary Supplement: Bifidobacterium lactis<br>* 5 billion active Bifidobacterium lactis<br>Dietary Supplement: Bifidobacterium lactis plus İnülin<br>* 5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given<br>* Other names: 5 billion Bifidobacterium lactis plus 900 mg İnülin;Dietary Supplement: İnulin<br>* 900 mg inulin per day will be given<br>|
| Active Comparator: Bifidobacterium lactis plus İnülin<br>5 billion active Bifidobacterium lactis plus 900 mg İnülin per day | Dietary Supplement: Bifidobacterium lactis<br>* 5 billion active Bifidobacterium lactis<br>Other: Maltodextrin<br>* Maltodextrin<br>Dietary Supplement: İnulin<br>* 900 mg inulin per day will be given<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necrotizing enterocolitis | Developing of >= grade 2 necrotizing enterocolitis suggested by radiological investigation | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | length of hospital stay | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Necrotizing enterocolitis, Sepsis, Length of hospital stay, Mortality