A clinical trial to study the efficay of probiotic VSL#3/PP in preventing Necrotizing enterocolitis in preterm infants.
Phase 3
- Registration Number
- CTRI/2009/091/000556
- Lead Sponsor
- CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New delhi-110016
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 126
Inclusion Criteria
All preterm infants of birth weight ≤1800 grams
Preterm infants who survive for 3 days after birth.
Preterm infants who have started on the enteral feeds
Exclusion Criteria
Parents/guardian unwilling or unable to give informed consent and follow protocol.
Preterm Infants with major congenital malformation.
Refusal to participate in the study by parent/guardian
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proven NEC (grade II A or higher by <br> Bell?s classification)<br>2. Death <br>Timepoint: Every day continued till the subject completes 34 weeks of gestational age.
- Secondary Outcome Measures
Name Time Method <br>1.Suspected NEC<br>2.Sepsis defined as positive culture in one or more usually sterile biologic fluids: blood, CSF, catherterized urine with colony count more than 15,000 colony counts and peritoneal fluid<br>3.Sepsis as defined above due to organisms present in the probiotic<br>4.> grade 3 Retinopathy of Prematurity-per ophthalmologist<br>5.BPD (by physiologic definition)<br>6.PDA confirmed by echocardiography and/or treated medically and/or surgically. Age of diagnosis in day will also be recorded<br>7.Days on antibiotics<br>8.Feeding intolerance as defined in Bell?s classification as IA and IB<br>9.Age to achieve full feed (100 cc/kg/day)<br>10.Growth rate (gm/day after regaining BW to d/c)<br>11.Line days (PICC Line/IV TPN)<br>12.Urinary tract infections<br>Timepoint: Till the subect completes 34 weeks of gestational age.