| CTRI Number |
CTRI/2024/09/074371 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Is Iron deficiency Anaemia in children aged 1 month to 5 years risk factor for acute lower respiratory tract infections |
|
Scientific Title of Study
|
Study of Iron deficiency Anaemia in children under 5 years of age admitted with acute lower respiratory tract infections |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDCAswani |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
Department of Paediatrics,KMC,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7075155288 |
| Fax |
|
| Email |
duragam.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRamesh Bhat Y |
| Designation |
Professor and HOU |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
Department of Paediatrics,KMC,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686401313 |
| Fax |
|
| Email |
ramesh.bhaty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrLeslie Edward Lewis |
| Designation |
Professor and HOD |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
Department of Paediatrics,KMC,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslie.lewis@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital , Tiger circle road, Madhav nagar, Eshwar nagar, Manipal,Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [NIL] |
|
|
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 DC Aswani |
Kasturba Medical College and Hospital |
Women and Children block,Department of Paediatrics,Kasturba Medical College,Manipal-576104,Udupi,Karnataka
Udupi
KARNATAKA |
7075155288
duragam.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
All children in the age group 1 month to 5 years who were admitted in the Department of paediatrics, Kasturba Hospital , Manipal with acute lower respiratory tract infections and having iron deficiency anaemia. |
|
| ExclusionCriteria |
| Details |
1.Children on therapeutic iron supplements
2.Children with major congenital anomalies or syndromes
3.Children with severe systemic illness,those receiving mechanical Ventilation /inotropes
4. Children with diagnosis of asthma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the frequency of iron deficiency anaemia in children aged 1month to 5 years admitted with acute lower respiratory tract infections
|
On day 2-3 of admission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
06/10/2024 |
| 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="6"
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
|
All children with acute lower respiratory tract infections will be included after application of inclusion and exclusion criteria , detailed history will be taken and clinical examination findings will be entered in pre designed proforma . investigation reports of CBC , RBC indices, Peripheral smear, CRP , serum iron , ferritin , TIBC will be obtained and frequency of Iron deficiency will be studied . |