| CTRI Number |
CTRI/2012/08/002853 [Registered on: 03/08/2012] Trial Registered Prospectively |
| Last Modified On: |
05/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of the Effect of Probiotic organism administration on Feeding Tolerance in Very Low Birth Weight Newborn babies |
|
Scientific Title of Study
|
Effect of Probiotics on Feed Tolerance in Very Low Birth Weight Neonates- A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShashidharA |
| Designation |
DM neonatology resident |
| Affiliation |
St.Johns medical college,Rajiv Gandhi University of health Sciences Bangalore |
| Address |
Senior resident
Dept.of Neonatology
St.Johns Medical College
Koramangala
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
|
| Fax |
|
| Email |
shashiishere@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrSwarnarekhaBhat |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
Senior resident
Dept.of Neonatology
St.Johns Medical College
Koramangala
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
|
| Fax |
|
| Email |
srekha74@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrShashidharA |
| Designation |
|
| Affiliation |
|
| Address |
Senior resident
Dept.of Neonatology
St.Johns Medical College
Koramangala
Bangalore
Bangalore KARNATAKA 560034 India |
| Phone |
|
| Fax |
|
| Email |
shashiishere@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrShashidharA |
| Address |
Dept of Neonatology
St Johns Medical college
BANGALORE |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrShashidharA |
Department of NeonatologySt Johns Medical College |
Sarjapur Road
Koramangala
Bangalore KARNATAKA |
9916069965
shashiishere@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Review Board |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary care givers of high risk neonates. |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
breast milk |
breast milk only |
| Intervention |
probiotic satchets |
Lactobacillus Spp,Bifidobacter Spp,Saccharomyces boulardi
oral 1 satchet once a day orally mixed in breast milk till discharge |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All neonates (infants in the first 28 days of life) with a birth weight less than 1.5kg, admitted to NICU SJMCH Bangalore. Postnatal age <2wks and started enteral feeds. |
|
| ExclusionCriteria |
| Details |
• Neonates GI tract anomalies, severe congenital malformations.
• Refusal of consent.
• Not started enteral feeds by day 14 of life.
• Outborn babies fed within 72 hrs
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time to reach full enteral feeds |
till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o incidence of feed intolerance
o incidence of NEC stage 2 or more
o duration of hospital stay
o days on TPN
o weight gain
o mortality
|
till diascharge |
|
|
Target Sample Size
|
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)
|
31/08/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Enteral feeding intolerance is a major problem in premature infants, resulting in prolonged hospitalisation and a predisposition to serious complications due to prolonged use of parenteral nutrition.Second to prematurity, feedings and feeding practices are frequently implicated in the development of necrotizing enterocolitis. Enteral supplementation of probiotics prevents severe NEC and all-cause mortality in preterm infants. Review of available evidence supports a change in practice Following recent data, many centres are currently supplementing preterm infants routinely with probiotics. Feeding intolerance has been considered as a precursor of NEC and many strategies have been tried in its prevention.Probiotics by themselves, or stimulated by prebiotic fermentation, are important modulators of the intestinal immune system, helps to produce a balanced T-helper cell response and prevents an imbalance contributing in part to clinical disease. An adequate establishment of the intestinal flora after birth is strictly related to motility maturation and plays a crucial role in the development of gut barrier function and the innate and adaptative immune system. In some RCTs done for prevention of NEC, probiotics have been shown to reduce time to full feeds, hospitalization days and days on total parenteral nutrition (TPN). |