To study the effects of two probiotic strain in preterm infants.
Phase 3
- Conditions
- Health Condition 1: null- Feeding Intolerance and NEC and late onset sepsis
- Registration Number
- CTRI/2017/06/008907
- Lead Sponsor
- Dr Sandeep Kadam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Gestation less than 33 weeks
2. birth weight less than 1500 gms
3. ready to commence on enteral feed or on enteral feed for less than 12 hours
Exclusion Criteria
1. major congenital malformation
2. chromosomal aberration
3. no consent
4. on enteral feeds for more than 12 hours
5. contraindication for enteral feeding
6. life threatening illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Safety: Assessed by monitoring for blood culture positive sepsis by the administered probiotic strains (2) Tolerance: The tolerance to study supplement will be assessed by monitoring for adverse effects such as abdominal distension, vomiting, and diarrhea leading to cessation of the supplementation (3) Effect on fecal microbiota: Lactobacillus counts will be determined by qPCR method.Timepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method (1) Incidence of NEC â?¥Stage II (2) All-cause mortality (3) Composite of NEC â?¥Stage II/all-cause mortality (3) Blood culture positive late onset sepsis (LOS) beyond 72 hours of life (4) Time to reach full enteral feeds (TFF: 150 ml/kg/day).Laboratory based: (5) Fecal bifidobacteria countsto be determined qPCR (6) Fecal metagenomics.Timepoint: 4 weeks