| CTRI Number |
CTRI/2017/12/010881 [Registered on: 14/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Cluster Randomized Trial |
Public Title of Study
Modification(s)
|
Pneumonia interventional study in Maharashtra |
Scientific Title of Study
Modification(s)
|
Pneumonia Research Initiative in Rural Areas and Urban Slums of Maharashtra |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Jayashree Gothankar |
| Address |
Bharati Vidyapeeth University Medical College Off Pune-Satara Road Dhanakwadi Pune
31-meghana Society Dhomkar Road, Sahakarnagar no.2 Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9423037645 |
| Fax |
|
| Email |
jayashreesg@rediffmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Jayashree Gothankar |
| Address |
Bharati Vidyapeeth University Medical College Off Pune-Satara Road Dhanakwadi Pune
31-meghana Society Dhomkar Road, Sahakarnagar no.2 Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9423037645 |
| Fax |
|
| Email |
jayashreesg@rediffmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Jayashree Gothankar |
| Address |
Bharati Vidyapeeth University Medical College Off Pune-Satara Road Dhanakwadi Pune
31-meghana Society Dhomkar Road, Sahakarnagar no.2 Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9423037645 |
| Fax |
|
| Email |
jayashreesg@rediffmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Bill and Melinda Gates Foundation
Address
500 Fifth Avenue North
Seattle, WA 98109, USA
(206) 709-3100
|
|
|
Primary Sponsor
|
| Name |
Bill and Melinda Gates Foundation |
| Address |
500 Fifth Avenue North
Seattle, WA 98109
(206) 709-3100 |
| Type of Sponsor |
Other [NGO] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| The INCLEN Trust International |
F-1/5, Okhla Industrial Area Phase - 1, New Delhi, Pocket F, Okhla Phase I, Okhla Industrial Area, New Delhi, Delhi 110020 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayashree Gothankar |
Pune |
Bharati Vidyapeeth Deemed University Medical College ,Off Pune Satara Road, Dhanakawadi,Pune.
Pune
|
9423037645
jayashreesg@rediffmail.com |
| Dr G B Dhumale |
Sangli |
Bharati Vidyapeeth Deemed University Medical College,Dept. of Community Medicine Sangli
Sangli
|
9423385979
girish.dhumale@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Institutional Ethics Committee office 4 Floor Bharati hospital and Research Centre Pune- Satara Road Dhankawadi Pune-411043 |
Approved |
| Department of Pharmacology Bharati Vidyapeeth Deeemed University Medical College and Hospital Sangli Dist. Sangli-416414 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pneumonia in under five children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioral change communication activities |
Behavioral change communication activities (Health education ) for mother of under five children for following topics: 1.Nutrition of child,2. Immunization, 3. indoor air pollution, 4.hand hygiene and cough etiquettes 5.Signs and symptoms of pneumonia |
| Comparator Agent |
Non implementation of Behavioural Change Communication activity in the comparison arm of the study |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
mothers of under five children in the selected cluster |
|
| ExclusionCriteria |
| Details |
mothers of under five children who intend to stay for less than six months or residing less than six months in the selected cluster |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Pneumonia amongst children of under five year old |
At the end of surveillance phase of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
prevalence of diarrhoea
|
At the end of surveillance period of one year |
|
|
Target Sample Size
|
Total Sample Size="4000"
Sample Size from India="4000" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2016 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No publications done |
Brief Summary
Modification(s)
|
The study evaluated the role of community-based interventions including BCC
activities for mother in the reduction of
pneumonia among under five-year-old children. Design: cluster randomized control trial(C-RCT)
with two arms of an equal number of clusters.
Population: children up to 5 years of age. Intervention: The community-based intervention consisting of three behavioral change communication (BCC)
activities for mothers of under-five
children. The domain areas addressed in the BCC activity were child feeding practices, immunization,
indoor air pollution, hand hygiene of mother, knowledge attitude and practices
of mother about pneumonia, cough etiquettes.
The BCC was implemented by project
appointed and trained field workers. Surveillance/Follow up: Was done at the fortnightly interval by ASHA or Anganwadi workers in both the arms for a period
of 12 months. The primary
outcome: WHO Integrated Management of Childhood Illness (IMNCI)-defined
pneumonia episodes in children under 5 years of age. Diagnosis confirmed by physicians. The trial was registered with the clinical trial registry of India with Trial no.
CTRI/2017/12/010881.We enrolled 3980 children across 16
clusters between 15th Feb 16 till 30 June 2017. And a total of 79,679 surveillance visits
were given. The pneumonia incidence rate in the intervention
arm was 2.2 per 100 child years and in the control group was 1.5 per 100 child
years(P<0.05).
Interpretation: The trial did not show
evidence that an intervention comprising BCC activities of mother reduces the risk of pneumonia in young
children. |
