A clinical trial to determine whether prophylatic administration of Probiotic Bifidobacterium breve to preterm infants reduces the incidence of episodes of Late onset sepsis
Phase 3
- Conditions
- Health Condition 1: P36- Bacterial sepsis of newborn
- Registration Number
- CTRI/2019/04/018393
- Lead Sponsor
- ational Health Mission
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Preterm babies gestational age between 28 weeks and 31 6/7 weeks or less than 1500 grams
Age less than 72 hours
Exclusion Criteria
Lethal congenital malformation known at trial entry
Any known Major gastrointestinal malformation or Medical indication preventing initiation of enteral feed within 72 hours of life.
Babies requiring More than two inotropic support
Babies with positive CRP or growth in blood culture within 72 hours of life
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of blood culture positive Late onset SepsisTimepoint: Everyday continued till subject complets 34 weeks
- Secondary Outcome Measures
Name Time Method 1.Age at achieving full enteral nutrition2.Number of episodes of feed intolerance3.Duration of total parenteral nutrition days4.Incidence of Necrotising Enterocolitis 5.Total number of Deaths before discharge from hospital 6.Total duration of antibiotics received <br/ ><br>Timepoint: Till the subject completes 34 weeks of gestation