The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Necrotizing Enterocolitis
- Sponsor
- Dr. Sami Ulus Children's Hospital
- Enrollment
- 400
- Locations
- 4
- Primary Endpoint
- Necrotizing enterocolitis
- Last Updated
- 13 years ago
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.
Investigators
Dilek Dilli
Assoc Prof
Dr. Sami Ulus Children's Hospital
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
Outcomes
Primary Outcomes
Necrotizing enterocolitis
Time Frame: 8 weeks
Developing of \>= grade 2 necrotizing enterocolitis suggested by radiological investigation
Secondary Outcomes
- length of hospital stay(16 weeks)