| CTRI Number |
CTRI/2024/06/069230 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Ratio of blood cells in Under five Malnourished Children
|
|
Scientific Title of Study
|
Neutrophil To Lymphocyte Ratio In Under-Five Children With Severe Acute Malnutrition |
| Trial Acronym |
NOT APPLICABLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kajal Makkar |
| Designation |
Post-graduate resident |
| Affiliation |
University College of Medical Sciences & GTB Hospital |
| Address |
Department of Pediatrics University College of Medical Sciences & GTB Hospital
North East
DELHI
110095
India |
| Phone |
7009156848 |
| Fax |
|
| Email |
kajalmakkar66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Narang |
| Designation |
Director Professor, Department of pediatrics |
| Affiliation |
University College of Medical Sciences & GTB Hospital |
| Address |
Department of Pediatrics University College of Medical Sciences & GTB Hospital
North East
DELHI
110095
India |
| Phone |
9811036569 |
| Fax |
|
| Email |
manish_2710@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Makkar |
| Designation |
Post-graduate resident |
| Affiliation |
University College of Medical Sciences & GTB Hospital |
| Address |
Room no. 10, Paediatrics OPD, Department of Pediatrics University College of Medical Sciences & GTB Hospital
North East
DELHI
110095
India |
| Phone |
7009156848 |
| Fax |
|
| Email |
kajalmakkar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences, Dilshad Garden , North-East Delhi,India,Pincode-110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences |
| Address |
Dilshad Garden, North East Delhi
Pincode-110095,India |
| 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 Kajal Makkar |
UCMS & GTB HOSPITAL |
Department of Pediatrics, Mch Block,4th Floor, GTB Hospital, Dilshad Garden, North East Delhi
North East
DELHI |
7009156848
kajalmakkar66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research, University college of medical sciences, University of Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
Children diagnosed with SAM (aged 6month-59month) as per WHO criteria 2013, which is defined as any one of the following
1.weight-for-length/height less than -3SD
2.MUAC less than 11.5
3.Bilateral pitting pedal edema of nutritional
origin.
|
|
| ExclusionCriteria |
| Details |
Children with
1 Known hematological disorders
2.History of blood transfusion in last 4 weeks
3.Taking the any immunosuppressant drugs
4.Immunodeficiency disorder
5.History of antibiotics in last 2 weeks
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome: To compare the NLR between children with good clinical outcome and those with poor clinical outcome.
|
Till discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes:
1. Duration of hospital stay
2. Recovery
3. Mean platelet volume
4. Lymphocyte count
|
Till discharge or death |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
25/06/2024 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Burden of under-nutrition among under-five children in India is still high.Early detection and management of children at high risk can help in improved outcome. Newer hematological indices/ratios are emerging as markers of inflammation/infection such as Neutrophil-to-lymphocyte ratio (NLR) representing both innate as well as adaptive immunity of body through neutrophils and lymphocytes, respectively. NLR has been evaluated in diagnosis of neonatal sepsis, bacterial / viral pneumonias, febrile seizures, acute appendicitis, asthma, pediatric inflammatory bowel disease, and as predictor of outcome in pediatric intensive care units. In various studies it has been found that higher NLR values were associated with poor outcome.Limited literature is available about the status of NLR in children with severe acute malnutrition.We planned this study to find association between hematological indices and the outcome in children with SAM and for this we will include NLR as our primary marker during this study. |