| CTRI Number |
CTRI/2018/01/011079 [Registered on: 01/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Probiotics for prevention of necrotising enterocoilitis in preterm neonates. |
|
Scientific Title of Study
|
A prospective, open label study to determine the effectiveness of probiotics in prevention of necrotizing enterocolitis in preterm admitted in tertiary care centre nicu, pediatric department sir t. Hospital, bhavnagarâ€ADMITTED IN TERTIARY CARE CENTRE NICU, PEDIATRIC DEPARTMENT SIR T. HOSPITAL, BHAVNAGAR†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahendra Rathod |
| Designation |
resident doctor |
| Affiliation |
Department of Pediatrics,Govt. medical college,Bhavnagar |
| Address |
Department of Pediatrics,sir Takhtsinhji hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9998042151 |
| Fax |
|
| Email |
dr.mahendrarathod01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJayendra Gohil |
| Designation |
head of department |
| Affiliation |
Department of Pediatrics,Govt. medical college,Bhavnagar |
| Address |
Department of Pediatrics,sir Takhtsinhji hospital, Bhavnagar
Department of Pediatrics,sir Takhtsinhji hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426348908 |
| Fax |
|
| Email |
jayendragohil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahendra Rathod |
| Designation |
resident doctor |
| Affiliation |
Department of Pediatrics,Govt. medical college,Bhavnagar |
| Address |
Department of Pediatrics,sir Takhtsinhji hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9998042151 |
| Fax |
|
| Email |
dr.mahendrarathod01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahendra Rathod
resident doctor,dept. of pediatics,govt. medical college,Bhavnagar,Gujarat. |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics Bhavnagar |
| Address |
Department of Pediatrics,sir Takhtsinhji hospital, Bhavnagar |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Mahendra rathod |
Sir thakhtsinhji hospital,Bhavnagar |
Neonatal intensive care unit
Bhavnagar
GUJARAT |
9998042151
dr.mahendrarathod01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, Preterm newborn
1.gestational age 28 to 34 weeks of both genders
2.Birth weight of ≤ 2kg or less
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
giving probiotics |
50% of preterm newborn are given probiotics while rest 50% are not given probiotics. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Preterm baby
1.gestational age 28 to 34 weeks
2.Birth weight of ≤ 2kg
|
|
| ExclusionCriteria |
| Details |
Preterm newborn
1.Birth weight>2kg
2.Lethal Congenital malformation
3.Newborn on ventilator
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| No occurrence of necrotisinig enterocolitis |
after 7 days of introducing probiotics
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No occurrence of necrotisinig enterocolitis |
06 months
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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 4 |
|
Date of First Enrollment (India)
|
28/09/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
NECROTIZING ENTEROCOLITIS (NEC) is preterm neonate is a major cause of mortality and morbidity. with the use of probiotics we can minimize the occurrence of NEC and can reduce subsequent events.i will be choosing high risk preterm newborns for my study.in 50% of neonate i will be giving probiotics and will keep rest 50% without it and will be studying occurrence of changes of NEC in both the groups. |