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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2009
INTERVENTION: Intervention1: VSL#3/PP: Dose will be one capsule of VSl#3/PP once daily mixed in at least 2 ml of breast milk or standard formula milk till the neonate (study subject) completes 34 weeks of age. Control Intervention1: Placebo: One capsule daily mixed in at least 2 ml of breast milk or standard formula milk till the neonate (study subject) completes 34 weeks of age. CONDITION: Necrotizing Enterocolitis in preterm infants PRIMARY OUTCOME: 1. Proven NEC (grade II A or higher by ; Bell?s classification); 2. Death ; ‐‐‐‐‐‐Timepoint: Every day continued till the subject completes 34 weeks of gestational age. SECONDARY OUTCOME: ; 1.Suspected NEC; 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; 3.Sepsis as defined above due to organisms present in the probiotic; 4.> grade 3 Retinopathy of Prematurity‐per ophthalmologist; 5.BPD (by physiologic definition); 6.PDA confirmed by echocardiography and/or treated medically and/or surgically. Age of diagnosis in day will also be recorded; 7.Days on antibiotics; 8.Feeding intolerance as defined in Bell?s classification as IA and IB; 9.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; ‐‐‐‐‐‐Timepoint: Till the subect completes 34 weeks of gestational age. 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
Epistemonikos ID: 32b29e56bb4599aa72ae65c89269b6132d7ef3b6
First added on: Aug 22, 2024