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

A randomized, double-blind, placebo controlled trial for prevention of Necrotizing enterocolitis in preterm infants with the probiotic VSL#3/PP.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000556

Enrollment

126

Registered

2009-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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. Cont

Eligibility

Inclusion criteria

Inclusion criteria: All preterm infants of birth weight &#8804;1800 grams Preterm infants who survive for 3 days after birth. Preterm infants who have started on the enteral feeds

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

India

Contacts

Public ContactDr. Arvind Saili

sailiarvind@gmail.com+91-98681 17699

Outcome results