| CTRI Number |
CTRI/2021/03/031622 [Registered on: 01/03/2021] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Implementation Research |
| Study Design |
Other |
|
Public Title of Study
|
To scale up appropriate pneumonia treatment in children under 5 years of age |
|
Scientific Title of Study
|
Implementation research to promote treatment of pneumonia in under-five children in a north Indian district to achieve high population-based coverage |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies
45 Kalu Sarai, New Delhi
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sonia Trikha |
| Designation |
Director General Health Services |
| Affiliation |
Department of Health, Haryana |
| Address |
Panchkula, Haryana-134109
Panchkula
HARYANA
134109
India |
| Phone |
0172-2590629 |
| Fax |
|
| Email |
dghsprog@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Barsha Gadapani Pathak |
| Designation |
Research scientist and Young Investigator |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies
45 Kalu Sarai, New Delhi
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
barsha.pathak@sas.org.in |
|
|
Source of Monetary or Material Support
|
| World Health Organization, Appia 20, Geneva 1211, Switzerland |
|
|
Primary Sponsor
|
| Name |
Centre for Health Research and Development Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi |
| Type of Sponsor |
Other [Research Organisation] |
|
|
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 Sarmila Mazumder |
Centre for Health Research and Development, Society for Applied Studies |
Centre for Health Research and Development, Society for Applied Studies,
Village Jatola,
District Palwal,
Tatarpur
Faridabad
HARYANA |
011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Review Committee, Centre for Health Research and Development, Society for Applied Studies |
Approved |
| World Health Organisation, Ethics Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
Children aged 0 day to 59 months with symptoms of pneumonia residing in the catchment area |
|
| ExclusionCriteria |
| Details |
– Non consent to participation
- Children with hypoxemia and danger signs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To promote pneumonia treatment in under-five children to achieve high and effective population-based coverage, defined as 80% or more under-five children in the defined study area, receiving the full course of pneumonia treatment, as recommended in Government of India Childhood Pneumonia Management Guidelines in under-five children. |
Baseline, and End-line |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To assess the proportion of children who recovered after 7 days of treatment
To assess the proportion of children with treatment failure
To assess the compliance to pneumonia treatment among the under-five children who receive the treatment.
To assess the proportion of children who complied with hospital referral as recommended in the guidelines
|
0 to 14 days of treatment |
| To promote care seeking and treatment of pneumonia in the girl child in the context of “Save the girl child†(Beti Bachao) programme of the government. |
Cross-sectional surveys |
| To ascertain knowledge, perception and experiences of health facility staff, community health workers and beneficiaries, around implementation of pneumonia management. |
Endline |
To ascertain knowledge, perception and
experiences of health facility staff, community
health workers and beneficiaries, around
implementation of pneumonia management
To document the duration of stay and treatment received in the in-patient department of the hospitals in children who accepted hospital referral. |
Study end point |
|
Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="120"
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)
Modification(s)
|
01/11/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is implementation research that will be done in close collaboration with the government of Haryana. The aim is to achieve high and effective coverage of pneumonia treatment in under-five children in a defined catchment area of 14 health and wellness centers (HWC) in the district of Palwal, Haryana. For the treatment of pneumonia in under-five children, the childhood pneumonia management guidelines recommended by the Government of India for under-five children will be followed. Treatment will be provided by the government health care providers in the HWCs, Primary Health Centers (PHCs), Community Health Centers (CHCs) , and District Hospital. The government health care providers will be trained in the appropriate management of pneumonia. The formal private sector may be involved in consensus with the government. The population of the catchment areas of the 14 Health Wellness Centers in Palwal district is around 1,40,000 and has 45 villages and 7 Primary Health Centers in the district. The study will include formative research to identify barriers and facilitators in the implementation of pneumonia treatment through in-depth interviews and focus group discussions. An implementation strategy will be developed by testing iterative models to achieve high coverage. An independent team will assess the outcomes through baseline, and end-line cross-sectional surveys in the study area. |