Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02473796 |
| Other study ID # |
MT-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 10, 2015 |
| Last updated |
March 15, 2016 |
| Start date |
January 2004 |
| Est. completion date |
April 2010 |
Study information
| Verified date |
March 2016 |
| Source |
MAHAN Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
India: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
Melghat is poorly developed tribal area in India with very high child mortality &
malnutrition prevalence (grossly inadequate medical facilities). Important health problems.
Malnutrition , Pneumonia, Tuberculosis, Anaemia, Malaria, Diarrhoea, Premature and L. B. W.
babies, Neonatal sepsis, Feeding problem, Birth asphyxia. The investigators developed a Home
Based Child Care (HBCC) model to reduce neonatal mortality rate (NMR), infant mortality rate
(IMR), under 5 mortality rate (U5MR) and severe malnutrition(SM) in this region.
Melghat.
Need of project :
Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the
research:. The results obtained in this area will be applicable for reducing children
mortality and malnutrition in other parts of Melghat and all other tribal areas of India.
Methodology: RCT-Home based child care (HBCC) by trained village health workers .(ARI,
Diarrhoea, Malaria clinically & Neonatal care) in 19 villages. Strengthening of existing
government ICDS and health system.
Melghat.
Need of project :
Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the
research:. The results obtained in this area will be applicable for reducing children
mortality and malnutrition in other parts of Melghat and all other tribal areas of India.
Methodology: RCT- (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria
clinically & Neonatal care) in 19 villages.
Description:
A. Objectives:
1. To reduce NMR from existing 54 ( year 2004) to 33.6 per 1000 live births in usual
residents population of 17000 (from 19 villages in tribal area of Melghat ) over a
period of 5 years.
2. To reduce the IMR from existing 90 (year 2004) to 52.65 per 1000 live births in above
area.
3. To reduce the U5MR from existing 140 (year 2006) to 72.1 per 1000 live births in above
area.
4. To reduce the prevalence of severe malnutrition (under 5 children ) from existing 9.5%
(year 2004) to 4.55% in above area.
B. Detailed research plan. I. Study design: Randomised Control Trial. The Melghat area was
divided into 5 clusters. 8 villages were randomly selected from each cluster by lottery
method. All under 5 children who are ill will be treated by trained VHW.
II. Study period: January 1st, 2004 to 31st April, 2010. III. Study area: 19 villages for
intervention and control area with Population of 14888 & 16310 respectively.
IV) Contents of the home based child health Package:
A. Provision of home based health care. It comprises provision of home-based health care to
pregnant mothers and under 5 children through a trained semi-literate female village health
worker (VHW) resident of the same village under medical supervision by trained medical
supervisor.
Arms Experimental: Home based child care The home based child care included treatment of
various childhood illnesses by VHWs, improving hygiene and nutrition among children and
women through health education.
Assigned interventions Home based child care Other Names: HBCC included treatment of
neonatal sepsis with Gentamicin once daily (5 mg for 10 days for preterm babies with birth
weight <2000g; 7 mg for birth weight 2000-2500 gm or as per gentamicin chart for 7 days for
normal term & weight ) by intramuscular injection.
Acute respiratory infection was treated with co-trimoxazole syrup BID (2.5 ml for age 1-2
months, 5 ml for age 2 months - 1 year, 7.5 ml for age 1 - 5 years).
Diarrheal illness was treated with ORS, furoxone (5 ml 8 hourly for 3 days) and
metronidazole syrup (5 ml 8 hourly for 7 days).
Malaria was treated with Syrup chloroquine (for 1 month to 1 year- 5 ml first dose , 2.5 ml
after 6 hours, 2.5 ml after 12 hours , 2.5 ml after 12 hours). Syrup paracetamol was given
2.5 to 5 ml 8 hourly depending upon the body weight.
Placebo Comparator: control The control arm included population where the HBCC was not
implemented.
Both arms: The health services were provided by the Government run primary health care
services. Vital statistics data was collected by VHWs.
D) Studies of prevalent knowledge and attitudes of the community regarding maternal and
child health .
V) The team of workers under the program are as follows:
i) VHW: 19 Trainer and guide of the VHWs: ii) 2 medical supervisors, iii) 2 nutrition
supervisors iv) 2 vital statistic supervisors.
v) The Traditional Birth Attendant (TBA). vi) A project manager. vii) One doctor will guide,
train, examine neonates (1st day) and evaluate the program.
VI. Implementation of HBCC
HBCC is a community-based project and following are the main components:
Micro plan preparation includes following:
i) Objectives, activities and methods. ii) Area & socio-economic profile. iii) Map of the
area. iv) Distribution and allocation of villages to VHW: v) Clear definitions of roles and
responsibilities of workers. vi) GANTT chart vii) VHW's emolument or earning. viii)
Check-list for supervisor & VHW activities. x) Community involvement xi) Budget xii) KAP of
traditional care. xiii) TBAs involvement xiv) Placement of the supervisor VII.
1. The total duration of training for supervisors and VHWs is 45 days. 2. TBAs are trained
in three workshops each of two-day duration.
VIII. Collection of Vital Statistics: VHWs will collect death and birth records. The vital
statistics supervisor will supervise it. Retrospective surveyor will conduct house-to-house
survey every six months to collect these data independently. TBAs will assist.
IX. Monitoring & Evaluation of project:
Monitoring indicators for the objective:
Monitor monthly: No. of pregnant ladies, VHW attendance during deliveries, No. of neonates
started breast feeding within 60 min, No. of patients treated, etc.
Evaluation of project:
A. External evaluation. B. Outcome evaluation - Mortality and morbidity (malnutrition ) will
be measured and reported in the outcome measure tables .
i ) NMR, IMR, CMR, ( children deaths per 1000 live births) ii) Prevalence of severe
malnutrition(SM). (percentage of children) The secondary outcome measure, prevalence of SM
was determined by weight of child in Kilogram versus age of child in months, in September of
each year. Indian Academy of Paediatrics classification was used for gradation of
malnutrition. Gr. III and IV =Severe malnutrition. Weight of child will be measured and
reported.
C. Process evaluation. Data analysis by Microsoft Excel and fox pro.
X. Phases: Three distinct phases are:
1. The first year of training, Observation, baseline data collection and recording.
2. Post-neonatal disease management from May 2005.
3. Providing HBCC services from May 2005 to April 2010. Data analysis from May 2010 to
July 2010.
XI. The physical inputs Items in the VHW Kit Wrist Watch, digital thermometer, Salter
weighing Scale. Adult weighing scale, Ambu bag, Warm bag , Blankets, Kangaroo mother care
blouse, Mucus extractor, Health education flipchart , Special spoon for feeding neonates,
etc. Tab Paracetamol 500 mg, Gentian violet paint 400 ml bottle, Injection Gentamicin vial 2
ml vial ( 40 mg per ml), Surgical cotton, Tab. Co- trimoxazole-Trimethoprim 20 mg
+Sulphamethoxazole 100 mg, Syrup Co- trimoxazole-Trimethoprim 40 mg +Sulphamethoxazole 200
mg , Spirit, Insulin Syringe, Tab Salbutamol- 2mg , Injection Vitamin K 10 mg ampoule.
Chloromycetin eye applicap. Oral Rehydration solution. Tab. Albendazole, Syrup Chloroquine ,
Tab. Furoxone, Syrup Furoxone, Syrup Metronidazole, Syrup Albendazole, Syrup Paracetamol,
Tab. Domperidone 5 mg, Tab. CPM. Antiseptic powder (10gram), Adhesive plaster, etc.
XII. Facilities available at the sponsoring institution:
Two full time well experienced post graduate doctors , trained VHWs(19), medical supervisors
(2) and project director. Facilities for hospitalization and training of VHWs.
XIII. Total Budget (costs)- The cost of implementation of HBCC may be around Rs.5646620 for
3 years. i. Staff: 2323850 ii. Contingencies 16000 Recurring: 3774999 Total Non-recurring:
1602725 iii. Audit & Administration: 268896.22
Annexure:
1. Activities under HBCC: Treatment of under 5 children, normal neonatal care , growth
monitoring & vital statistics data collection by VHWs in the intervention villages will be a
regular activity. Retrospective survey and data analysis of IA & CA will be conducted every
6 months.
Periodic activities are: Gramsabha, Program manager, project director village visit, Launch,
BCC- community or group health education, Counting of under 5 children once a year, Training
of VHW and supervisors, Weight record of under 5 children in intervention area, Midterm
evaluation, final data analysis and final evaluation by external agencies.
Annexure 2- Socioeconomic profile of intervention area. Melghat is hilly forest area with
317 villages in central India . Population is 2,50,000 & 75% of them are tribal . Most of
the tribal(>90 %) are farmers or labourers living very hard life, below poverty line(>75%) &
illiterate (>50%), living in huts(>90%).
Medical facilities are grossly inadequate. Annexure 3: Clear definitions of roles and
responsibilities of categories of workers.
The traditional birth attendant ( TBA)
1. Reinforce the health education messages given by VHWs to pregnant mothers and her
relatives.
2. Encourage mother to access ANC from the regular government health services.
3. Conduct hygienic and safe delivery.
4. Recognize danger signals in mother ( delivery, post-partum) and refer.
5. Insist that family calls VHW to assist her during delivery & work in collaboration with
VHW.
The village health worker (VHW): Job description under HBCC:
VHW is the direct provider of components of the HBCC. Record keeping of the target group and
work in smooth collaboration with TBA. Periodically visit every house and collect
information related to pregnancy and child health.
Refer pregnant women to ANM for iron, folic acid & tetanus toxoid injection. Organize and
assist supervisors in conducting group health education for pregnant women.
Make three antenatal visits to pregnant women in the village at 4th, 7th and 9th month of
pregnancy for health screening, health education, Danger signs in pregnancy, labour & action
to be taken. Planning for delivery & Breast feeding.
Attend delivery and observe baby
a. Record information on delivery and birth . b. Encourage cleanliness. c. Observe the
new-born baby at 30 seconds after birth for cry, respiration and movement of limbs.
d. Determine whether the baby is normal or asphyxiated or still birth: and if the baby is
not normal initiate asphyxia management.
g. Dry and wrap the baby h. Initiate breast-feeding. Provide care for the normal new-born .
Provide care for the high risk new-born. Give Vitamin K injection. Conduct 7 regular home
visits.
Identify and manage following problems in mother and new-born baby Asphyxia, Premature
birth, Low birth weight, Hypothermia, Breast feeding problem, Neonatal sepsis & Pneumonia.
Refer to hospital if no response in 24 hours.
Provide treatment to children of 1 months to 5 years and fill the forms for a. Pneumonia, b.
Diarrhoea and dysentery, c. Malaria. d. Management of malnutrition.
3) The trainer cum medical supervisor of the VHWs. The supervisor of the VHWs is responsible
for training of the VHWs in classrooms and on-going training in the field during supervisory
visits, providing support and guidance to the VHWs in their work.
Job Description :
I. Checking of medicine, equipments, forms , etc. II. Visit each new-born twice. III. Supply
medicines to VHW. IV. Examination of resistant malnourished cases. V. Conduct meeting of
pregnant women for Health Education. VI. Proper medicine stock record. VII. Visit to
patients treated by VHW. VIII. ANC B.P. record. IX. Monitoring immunization status.
4. Nutrition supervisor
1. Cross check 25% of all weights.
2. Preparation of Growth Chart & Grading of children.
3. Selection and enrolment of children & mothers for supplementary feeding.
4. Check the efficiency of weighing machine.
5. Health Education on nutrition .
6. Training & monitoring of VHW activities.
7. Arrange paediatrician visit to non-responding malnourished cases.
8. Survey of nutrition status & local food materials.
9. Motivation of people for use of local nutritious food material.
10. Identify specific nutrition deficiencies e.g. vitamin A deficiency.
11. Supply growth cards to PEM children. 5) The Project Manager The project manager has to
shoulder the responsibility of ensuring that the HBCC is provided properly and that the
desired outcome of reduction in mortality rates is achieved. Besides planning, resource
management, overseeing execution, monitoring and evaluation of the implementation of
the HBCC approach from time to time, specifically he has to undertake following
responsibilities.
1. Maintaining rapport with the community.
2. Making available existing infrastructure.
3. Recruitment and deployment of staff.
4. Organizing training.
5. Gathering data and its analysis through a competent organization.
6. Network management etc.
7. Ensuring availability of material.
8. Financial monitoring,
9. Preparing reports. Annexure :4 -Community Involvement including awareness, consent
and acceptance.
Community participation may be sought at the following stages:
Key person visits, Village meetings, The village should be invited to recommend potential
candidates for the work of VHWs, Launch meetings, Periodic interactions with the village to
give feedback and encourage suggestions, women's micro-credit groups , Village health
committee & Village Councils, etc
