A study of the Effect of Probiotic organism administration on Feeding Tolerance in Very Low Birth Weight Newborn babies
- Conditions
- Primary care givers of high risk neonates.
- Registration Number
- CTRI/2012/08/002853
- Lead Sponsor
- DrShashidharA
- Brief Summary
Enteral feeding intolerance is a major problem in premature infants, resulting in prolonged hospitalisation and a predisposition to serious complications due to prolonged use of parenteral nutrition.Second to prematurity, feedings and feeding practices are frequently implicated in the development of necrotizing enterocolitis. Enteral supplementation of probiotics prevents severe NEC and all-cause mortality in preterm infants. Review of available evidence supports a change in practice Following recent data, many centres are currently supplementing preterm infants routinely with probiotics.
Feeding intolerance has been considered as a precursor of NEC and many strategies have been tried in its prevention.Probiotics by themselves, or stimulated by prebiotic fermentation, are important modulators of the intestinal immune system, helps to produce a balanced T-helper cell response and prevents an imbalance contributing in part to clinical disease. An adequate establishment of the intestinal flora after birth is strictly related to motility maturation and plays a crucial role in the development of gut barrier function and the innate and adaptative immune system. In some RCTs done for prevention of NEC, probiotics have been shown to reduce time to full feeds, hospitalization days and days on total parenteral nutrition (TPN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 126
- All neonates (infants in the first 28 days of life) with a birth weight less than 1.5kg, admitted to NICU SJMCH Bangalore.
- Postnatal age <2wks and started enteral feeds.
- •Neonates GI tract anomalies, severe congenital malformations.
- •Refusal of consent.
- •Not started enteral feeds by day 14 of life.
- •Outborn babies fed within 72 hrs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to reach full enteral feeds till discharge
- Secondary Outcome Measures
Name Time Method oincidence of feed intolerance oincidence of NEC stage 2 or more
Trial Locations
- Locations (1)
Department of NeonatologySt Johns Medical College
🇮🇳Bangalore, KARNATAKA, India
Department of NeonatologySt Johns Medical College🇮🇳Bangalore, KARNATAKA, IndiaDrShashidharAPrincipal investigator9916069965shashiishere@gmail.com