Evaluation of the effect of probiotics on late-onset sepsis in very preterm newborns
Phase 3
Completed
- Conditions
- late-onset sepsis in very preterm infants.Bacterial sepsis of newborn, unspecified
- Registration Number
- IRCT20171218037936N1
- Lead Sponsor
- Oroumia University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
Preterm infants weighting 1000-1500 g and less than 32 weeks’ gestational age at birth
Enrolled within 48 hours of birth
Exclusion Criteria
Major congenital anomalies(Esophageal atresia,Omphalocele,Imperforate anus)
Major congenital heart malformations
Genetic anomalies(e.g Trisomy 21 or other trisomies)
Considered likely to die within 72 hours of birth
Death before minimal entral feeding(10-20cc/kg/day)
Parents from whom informed consent cannot be obtained
Sepsis in admission(CRP>10mg/dl in 1st day of admission)
Asphyxia (grade II, III)
Maternal chorioamnionitis
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate-onset sepsis. Timepoint: Baseline(admission), weekly and when clinical sepsis suspected. Method of measurement: Measurement of C-Reactive Protein and clinical clinical evaluation.
- Secondary Outcome Measures
Name Time Method ecrotizing enterocolitis. Timepoint: On admission, every week, when symptoms of Necrotizing enterocolitis are diagnosed. Method of measurement: Clinical evaluation based on Bell's Criteria.;Duration of primary hospitalization. Timepoint: Time of discharge. Method of measurement: Count the number of hospitalization days.;The number of days the infant takes to complete entral feeding(120mL/kg per day). Timepoint: During the study period. Method of measurement: number of days until an infant to eat 120mL / kg per day of milk.