| CTRI Number |
CTRI/2017/08/009544 [Registered on: 30/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
29/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of Oral zinc and Pre-Probiotics in neonatal sepsis |
|
Scientific Title of Study
|
Use of Zinc and Pre-Probiotics as a therapeutic adjunct in neonatal sepsis in preterms- An Open label 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 |
Dr Atul Londhe |
| Designation |
Assistant Professor Neonatology |
| Affiliation |
Govt Medical College, Aurangabad |
| Address |
Division of Neonatology
Department of Pediatrics
Govt Medical College, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
08275453997 |
| Fax |
|
| Email |
atul.londhe1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Londhe |
| Designation |
Assistant Professor Neonatology |
| Affiliation |
Govt Medical College, Aurangabad |
| Address |
Division of Neonatology
Department of Pediatrics
Govt Medical College,
Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
08275453997 |
| Fax |
|
| Email |
atul.londhe1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Londhe |
| Designation |
Assistant Professor Neonatology |
| Affiliation |
Govt Medical College, Aurangabad |
| Address |
Division of Neonatology
Department of Pediatrics
Govt Medical College
Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
08275453997 |
| Fax |
|
| Email |
atul.londhe1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neonatal Intensive Care Unit, Department of pediatrics, Govt Medical College Aurangabad |
|
|
Primary Sponsor
|
| Name |
Govt Medical College Aurangabad |
| Address |
Govt Medical College, Aurangabad |
| 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 |
| Dr Atul Londhe |
Govt Medical College, Aurangabad |
Neonatal Intensive Care Unit (NICU), Department of Pediatrics, Govt Medical College, Panchakki road, Aurangabad
Aurangabad
MAHARASHTRA |
08275453997
atul.londhe1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt Medical College, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All intramural preterm neonates admitted to NICU with proven sepsis , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Not receiving any of the above |
| Intervention |
Pre-Probiotics |
Pre-Probiotics group was given as Syrup 5ml per day containing L. acidophilus (1.25 billion), B.longum (0.125 billion), B. bifidum (0.125 billion), B. lactis (1 billion) and Inulin (25mg) till discharge. |
| Intervention |
Zinc |
Zinc group was given
oral zinc 10 mg once a day irrespective of age of newborn till discharge. |
| Intervention |
Zinc and Pre-Probiotics |
Zinc and Pre-Probiotic group was given both zinc 10 mg per day and Pre-Probiotics as Syrup 5ml per day containing L. acidophilus (1.25 billion), B.longum (0.125 billion), B. bifidum (0.125 billion), B. lactis (1 billion) and Inulin (25mg) till discharge. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All intramural preterm neonates from 28wk1day to 36wk6days admitted to NICU at GMCH Aurangabad with proven sepsis during the study period, whose parents consented to be part of the study were included.
Diagnostic criteria for sepsis was
(a) Positive ‘sepsis screen’ i.e. presence of at least two of the following three parameters, namely, Total leucocyte count <5000/mm3, Low absolute neutrophil count (as per standard charts), C-reactive protein>1mg/dl,
(b) Radiological evidence of pneumonia
(c) Culture positive sepsis
(d) Meningitis |
|
| ExclusionCriteria |
| Details |
Parental refusal to consent,
neonates < 28 weeks GA,
severe birth asphyxia,
life threatening congenital malformations, critically ill newborns within 24 hours of life, neonates with necrotizing enterocolitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Mortality |
at discharge/30 days of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for change to higher (2nd/3rd line) antibiotics |
At discharge/ 30 days of life |
| Need for supportive treatment i.e ventilation, inotropes, blood transfusion |
At discharge/ 30 days of life |
| Duration of hospital stay |
At discharge/ 30 days of life |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="124" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2015 |
| Date of Study Completion (India) |
31/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
RESULTS: A total of 124 newborns had proven
sepsis during the study period and all were randomised. Of 124, zinc group had
32, pre-probiotics had 32, zinc and pre-probiotics had 29 and control group had
31 cases. None of the cases were discharged AMA. No adverse effect
reported in any intervention group. In this study, we found baseline
characteristics were similar in all four groups (p>0.05).
When the final outcome in all four groups
were compared, we found significantly decrease in mortality in zinc
and pre-probiotics group (p=0.04).
Also, there is significant decrease in need for higher antibiotics in the same
(p=0.02). But need for supportive
treatment and duration of hospital stay did not differ significantly in any
group as compared with control (p>0.05). |