Necrotizing eneterocolitis, neonatal sepsis. Necrotizing enterocolitis of fetus and newborn, bacterial sepsis of newborn
Conditions
Interventions
Intervention 1: The study group received Saccharomyces boulardii (Reflor®, Biocodex, France, 50 mg/kg per dose twice daily) which were added to breast milk or formula until discharge. Intervention 2:
Treatment - Drugs
Placebo
The study group received Saccharomyces boulardii (Reflor®, Biocodex, France, 50 mg/kg per dose twice daily) which were added to breast milk or formula until discharge.
Sponsors
Health Ministry Drug and Pharmacy General Management
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Length 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. | — |
Countries
Turkey
Contacts
Public ContactGuner Karatekin
Zeynep Kamil Maternity and Children Education and Training Hospital
Outcome results
None listed