Outcome of Saccharomyces boulardii prophlaxis on necrotizing enterocolitis
Phase 3
- Conditions
- ecrotizing eneterocolitis, neonatal sepsis.Necrotizing enterocolitis of fetus and newborn, bacterial sepsis of newbornP77, P36
- Registration Number
- IRCT2012071410279N1
- Lead Sponsor
- Health Ministry Drug and Pharmacy General Management
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria
Very low birth weight infants (gestational age: =32 weeks; birth weight: =1500 g) who survived to feed enterally (minimum age: first postnatal day, maximum age: 1 week).
Exclusion criteria: Infants who had severe asphyxia (stage III), major congenital anomalies, those who had been fasted for more than 3 weeks, died within the first postnatal 14 days and infants who used antifungal therapy were excluded.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sepsis. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Necrotizing enterocolitis. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.
- Secondary Outcome Measures
Name Time Method ength of hospitalization. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Time to reach full enteral feeding. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients medical records.;Mortality until hospital discharge. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Weight gain per week. Timepoint: Starts on the 7th day of intervention. Method of measurement: Patients' medical records.;Neurocognitive development. Timepoint: 18 months corrected age. Method of measurement: Bayley test.