| CTRI Number |
CTRI/2018/04/013401 [Registered on: 20/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of prophylactic microbial supplements in prevention of blood stream infection and intestinal tract injury in premature neonates |
|
Scientific Title of Study
|
Role of prophylactic probiotics in prevention of necrotising enterocolitis and sepsis in premature neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gousia mukhtar |
| Designation |
Seniour resident |
| Affiliation |
Sher i kashmir institute of medical sciences, soura |
| Address |
Seniour resident, Department of Pediatrics and Neonatology
Sher i kashmir institute of medical sciences, soura srinagar
Srinagar
JAMMU & KASHMIR
190005
India |
| Phone |
9419063156 |
| Fax |
|
| Email |
gousiamukhtar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiekh Mushtaq Ahmad |
| Designation |
Professor |
| Affiliation |
Professor , Sher i kashmir institute of medical sciences, soura |
| Address |
Department of Pediatrics and Neonatology, Sher i kashmir institute of medical sciences, soura, srinagar
Srinagar
JAMMU & KASHMIR
190005
India |
| Phone |
9419041796 |
| Fax |
|
| Email |
drmushtaq816@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gousia mukhtar |
| Designation |
Seniour resident |
| Affiliation |
Sher i kashmir institute of medical sciences, soura |
| Address |
Seniour Resident, Department of Pediatrics and Neonatology
Sher i kashmir institute of medical sciences, SOURA, Srinagar
Srinagar
JAMMU & KASHMIR
190005
India |
| Phone |
9419063156 |
| Fax |
|
| Email |
gousiamukhtar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sher i kashmir institute of medical sciences, soura Srinagar |
|
|
Primary Sponsor
|
| Name |
Gousia mukhtar |
| Address |
185 house no
Sanat nagar housing colony Srinagar |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 |
| Gousia mukhtar |
Sher i kashmir institute of medical sciences, soura |
Sher i kashmir institute of medical sciences, soura Srinagar kashmir
Srinagar
JAMMU & KASHMIR |
9419063156
gousiamukhtar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SKIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
1. Necrotising enterocolitis
2. Nosocomial sepsis , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mixture of lactobacillus acidophilus, lactobacillus rhamnosus, bifidobacterium longum and streptomyces boulardii |
Mixture of lactobacillus acidophilus, lactobacillus rhamnosus, bifidobacterium longum and streptomyces boulardii in a dose of 1.25 billion CFU twice daily started with the first feed which can be in the form of expressed breast milk or preterm formula feed and continued till discharge |
| Comparator Agent |
The control group will receive expressed breast milk or preterm formula feed with no supplements added. |
The control group will receive expressed breast milk or preterm formula feed with no supplements added |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All infants admitted to our nicu with birth weight less than 2 kg or gestational age less than 35 weeks as assessed by EDD and further confirmed by Ballards score who survive the first 24 hrs of life will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
1. sepsis
2. Major congenital anomalies
3. Severe asphyxia
4. Severe IUGR
5. Immunocompromised host like hiv infected infants |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the safety and efficacy of prophylactic probiotics versus no treatment in prevention of
1.Necrotising colitis
2. Nosocomial sepsis
In preterm low birth weight babies |
1st of june 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of hospitalization
2. Time to establish full feeds
3.Episodes of feed intolerance
4. All cause neonatal mortality |
1st of june, 2018 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2012 |
| 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="5"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We compared the efficacy of prophylactic probiotics versus no treatment in prevention of necrotising enterocolitis and nosocomial sepsis in premature ( less than 35 weeks gestation ) , LBW infants (less than 2 kg weight ) Secondary outcomes to be measured are duration of hospitalization, time to establish full feeds , mortality and episodes of feed intolerance. We excluded infants who had sepsis, severe congenital malformation , were severely small for gestational age, had immunodeficiency or had severe asphyxia . |