Health Condition 1: null- Feeding Intolerance and NEC and late onset sepsis
Conditions
Interventions
Intervention1: probiotic supplementation: probiotic supplementation of 3 billion CFU/day of combined Lactobacillus plantarum MTCC 5690 and Lactobacillus fermentum MTCC 5689 or Lactobacillus plantarum
Sponsors
Dr Sandeep Kadam
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (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
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
India
Contacts
Public ContactDr Sandeep Kadam
KEM Hospital and Research Centre
Outcome results
None listed