| CTRI Number |
CTRI/2009/091/000556 [Registered on: 25/09/2009] |
| Last Modified On: |
14/09/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficay of probiotic VSL#3/PP in preventing Necrotizing enterocolitis in preterm infants. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo controlled trial for prevention of Necrotizing enterocolitis in preterm infants with the probiotic VSL#3/PP. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Arvind Saili |
| Designation |
|
| Affiliation |
|
| Address |
Professor,Department of Paediatrics
Lady Hardinge Medical College and associated Kalawati Saran Children's Hospital
New Delhi
DELHI
110001
India |
| Phone |
+91-98681 17699 |
| Fax |
+91-11-2336 5792 |
| Email |
sailiarvind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arvind Saili |
| Designation |
|
| Affiliation |
|
| Address |
Professor,Department of Paediatrics
Lady Hardinge Medical College and associated Kalawati Saran Children's Hospital
New Delhi
DELHI
110001
India |
| Phone |
+91-98681 17699 |
| Fax |
+91-11-2336 5792 |
| Email |
sailiarvind@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Arvind Saili |
| Designation |
|
| Affiliation |
|
| Address |
Professor,Department of Paediatrics
Lady Hardinge Medical College and associated Kalawati Saran Children's Hospital
New Delhi
DELHI
110001
India |
| Phone |
+91-98681 17699 |
| Fax |
+91-11-2336 5792 |
| Email |
sailiarvind@gmail.com |
|
|
Source of Monetary or Material Support
|
| CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New delhi-110016 |
|
|
Primary Sponsor
|
| Name |
CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New delhi-110016 |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Arvind Saili, Professor, Department of Pediatrics |
Department of Pediatrics, Lady Hardinge Medical College and Kalawati Saran Children's Hospital |
Department of Pediatrics, Lady Hardinge Medical College and Kalawati Saran Children's Hospital,-110001
New Delhi
DELHI |
+91-98681 17699
+91-11-2336 5792
sailiarvind@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Lady Hardinge Medical College and associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Necrotizing Enterocolitis in preterm infants, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
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. |
| Intervention |
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. |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
|
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
|
Till the subect completes 34 weeks of gestational age. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/12/2006 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |