A clinical trial to study the efficay of probiotic VSL#3/PP in preventing Necrotizing enterocolitis in preterm infants.

Phase 3

Not yet recruiting

• Conditions: Necrotizing Enterocolitis in preterm infants

• Registration Number: CTRI/2009/091/000556
• Lead Sponsor: CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New delhi-110016

Brief Summary

This study is a randomized, double blind, parallel group, multicentre trial to study the efficacy of probiotic VSL#3/PP in preventing Necrotizing enterocolitis in preterm infants; conducted in 200 patients in single center (LHMC, Kalawati Saran Children's Hospital) in New Delhi, india. Clinical activity will be defined as reduction in the incidence and severity of NEC or Death. Primary endpoints are to determine the incidence of Proven NEC (grade II A or higher by Bell's classification) and Death. Secondary outcomes are to determine the incidence of Suspected NEC; 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 ; Sepsis as defined above due to organisms present in the probiotic; > grade 3 Retinopathy of Prematurity-per ophthalmologist ; BPD (by physiologic definition) ; PDA confirmed by echocardiography and/or treated medically and/or surgically. Age of diagnosis in day will also be recorded; Days on antibiotics ; Feeding intolerance as defined in Bell's classification as IA and IB 9.Age to achieve full feed (100 cc/kg/day) ;Growth rate (gm/day after regaining BW to d/c) ; Line days (PICC Line/IV TPN) and Urinary tract infections.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-29
• Last Update Posted: 2011-09-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 126

Inclusion Criteria

All preterm infants of birth weight ≤1800 gramsPreterm 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 Bell?s classification)2. Death	Every day continued till the subject completes 34 weeks of gestational age.

Secondary Outcome Measures

Name	Time	Method
1.Suspected NEC2.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 fluid3.Sepsis as defined above due to organisms present in the probiotic4.> grade 3 Retinopathy of Prematurity-per ophthalmologist5.BPD (by physiologic definition)6.PDA confirmed by echocardiography and/or treated medically and/or surgically. Age of diagnosis in day will also be recorded7.Days on antibiotics8.Feeding intolerance as defined in Bell?s classification as IA and IB9.Age to achieve full feed (100 cc/kg/day)10.Growth rate (gm/day after regaining BW to d/c)11.Line days (PICC Line/IV TPN)12.Urinary tract infections	Till the subect completes 34 weeks of gestational age.

Trial Locations

Locations (1)

Department of Pediatrics, Lady Hardinge Medical College and Kalawati Saran Children's Hospital; 🇮🇳 Delhi, DELHI, India

Department of Pediatrics, Lady Hardinge Medical College and Kalawati Saran Children's Hospital

🇮🇳Delhi, DELHI, India

Dr. Arvind Saili, Professor, Department of Pediatrics

Principal investigator

sailiarvind@gmail.com