Outcome of synbiotics on necrotizing enterocolitis, sepsis
Phase 3
- Conditions
- Condition 1: Necrotizing enterocolitis. Condition 2: Sepsis. Condition 3: Hyperbilirubinemia.Necrotizing enterocolitis of fetus and newbornBacterial sepsis of newbornNeonatal jaundice from breast milk inhibitor
- Registration Number
- IRCT2013062710279N3
- Lead Sponsor
- OBEL Pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 210
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: 10 days). 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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ecrotizing enterocolitis. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Sepsis. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Hyperbilirubinemia. Timepoint: Starts at the same time with the intervention. Method of measurement: Serum sample.
- Secondary Outcome Measures
Name Time Method Weight gain per week. Timepoint: Starts on the 7th day of 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.;Length of hospitalization. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Neurocognitive development. Timepoint: 18 months corrected age. Method of measurement: Bayley test.