Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06130488 |
| Other study ID # |
2021-6444-19970 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
July 30, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Aga Khan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this quasi-experimental study design is to look at feasibility and document the
process and challenges of implementing KMC at scale in district Sanghar (Sindh) and Lasbella
(Balochistan)
. The main question it aims to answer are:
- Does the KMC is feasible to be implemented in rural areas?
- What is the process and challenges in implementing KMC in rural areas?
- Pregnancy surveillance is going in the secondary level care hospitals and in its
catchment population. Recruitment of babies is carried who are low birth weight (less
than 2000grams).
- Mothers taught to administer KMC by physician and nursing /LHV staff in the facility
within first 6 hours after delivery and continue till the mother and baby are discharged
by trained facility KMC management team.
- After training and administration of KMC at facility for 72 hours, the mother and baby
pair discharged and followed up at home by the team including project-based data
collector and respective LHWs.
- KMC Champions are in development for community mobilization and conducting sessions at
village level.
- We will compare pre and post intervention change in practices at facility level and at
individual level of household and assess the KMC coverage.
Description:
KMC Implementation
Pre KMC-Implementation phase (Community) Birth weight of all newborns in selected facilities
and home will be captured by trained lady health workers (LHW)/community health workers (CHW)
with digital scales. LHW/CHW will refer all 2000 g or less newborns to facilities for KMC.
LHWs will create community awareness and engagement to support and accept referral of
newborns for KMC through Village Health committee members (VHC) and by approaching existing
women support groups formed by LHWs during phase 1 of the project.
KMC Implementing Facilities
Training of Staff A total of 40 facility-based health care providers and 400 community-based
workers including LHWs/ LHVs in Sanghar and Lasbela will receive a three-day training session
on KMC & Essential newborn care followed by a one-day training on DHIS data record keeping.
KMC Facilities Preparation: Sustainable Provision of KMC and Essential Commodities/supplies
Spaces already present within the selected facilities will be identified to serve as KMC
rooms (curtained/ partitioned areas, toilets), so mothers can stay with their babies.
Facilities will contain essential equipment for maternal and newborn care such as ambu bags,
weighing scales for newborns, KMC packs, infant heaters, oxygen supply systems and pulse
oximeters.
Methodology
Study Design:
We have carried out formative research to identify barriers and design a model to deliver KMC
across the facility-community continuum. A quasi-experimental study design will be adopted.
District Health Information System (DHIS) data and service data on maternal and newborn
mortality and morbidity outcomes will be collected from health facilities. A pre and post
design will be undertaken to look at feasibility and document the process and challenges of
implementing this at scale.
Study population The study population are babies of birth weight less than 2000g delivered at
hospital or in community in the catchment area of 2 district in Sindh and Balochistan.
Study settings and location:
This model will be implemented in the facilities and their catchment communities of district
Sanghar and district Lasbela from July 2021 for 24 months. Four tehsils will be selected from
each district, health facilities accompanying in these tehsils are already identified along
with their catchment population to implement community arm of KMC. The facilities that will
implement KMC include DHQs, THQs and RHCs from public sector and private sector facilities.
And these facilities have been selected based on the availability of MNCH services and
logistics. These facilities are level two hospitals (DHQs & THQs) and MNCH centers (RHCs)
equipped with essential equipment's, supplies, drugs, basic laboratory test, immediate
referral and human resources. The monthly outpatient turnover of the maternal patients in
each of these hospitals on average 80 - 120 deliveries for DHQs and THQs takes place each
month.
Study Activities
Base line Survey:
The UeN midline survey will be used as baseline for this research and end-line surveys will
be conducted in 2023. The community KMC indicators will be; prevalence of low birth weight
babies, neonatal mortality, KMC practices, skin-skin contact, breast feeding practices,
immediate and essential newborn care practices, especial care of low birth weight babies
provided by families and care seeking behavior for newborns.
Pregnancy surveillance:
Pregnancy surveillance will be instituted through LHWs for detection of new pregnancies as a
continuous monthly activity throughout the study period. Families will be encouraged for
facility-based delivery and KMC will be administered to all Low-birth-weight babies
(<2000gms) delivered in the facility. The Pregnancy surveillance data will be validated by
data collectors during their monthly visit for Birth notification. Identified pregnancies
will be followed up by data collectors who will monitor sessions on KMC at household level to
orient pregnant mother and their families on KMC benefits, conducted by respective LHW. This
will be an antenatal sensitization activity. As soon as a home birth is notified,
district-based project staff will ensure LHW will visit the household within 72 hours of
birth. The screening will be carried out and babies with birth weight of 2000 gram or less
will be referred to KMC facility. After discharge from facility, the LHW will visit the
household on (days 7, 14, 21, and 28) and district team validate these visits to assess the
mother and baby and support kangaroo mother care practice.
Enrollment and KMC administration at Facility:
Low birth weight babies (<2000gms) delivered in facility will be enrolled at birth if they
fulfill eligibility criteria and following consent. KMC will be administered to all enrolled
babies. Mothers will be taught to administer KMC by physician and nursing /LHV staff in the
facility within first 6 hours after delivery and will continue till the mother and baby are
discharged by trained facility KMC management team.
Continuation of KMC administration at Community:
After training and administration of KMC at facility for 72 hours, the mother and baby pair
will be discharged and followed up at home by the team including project-based data collector
and respective LHWs. Team will conduct follow up visits daily for the first week, then weekly
basis for 6 weeks, then quarterly till 2 years of age to capture process indicators. Data
collectors will visit all households in the tehsils on the scheduled basis to ensure support
for providing KMC and reinforcement. For women who deliver low birth weight babies at home,
window period for enrolment will be 72 hours. KMC will be taught to them at home by LHWs and
validated by project-based staff. Their responsibility will be to support mothers in
practicing KMC. Community based Kangaroo Mother Care (cKMC) will be administered by LHWs only
to enrolled babies discharged from facilities and those born at home belonging to the
catchment population of already identified KMC facilities.
Community Mobilization (KMC Champions):
KMC Champions will be developed for community mobilization and conducting sessions at village
level. LHW / CHW with the support of village health committee and support groups will also
conduct one-to-one and group sessions with pregnant women, mothers and mothers-in-law on
essential newborn care and KMC practices. The sessions will be conducted at regular intervals
which validated and monitored by project-based district managers. LHW/CHW will also encourage
recruitment of volunteers to function as KMC champions. The local community members serving
as KMC champions will also serve as catalyst for mobilization. The mobilization staff will
also identify and encourage co-champions (a stream of volunteers from the community) who will
be mentored by KMC champions. This group of local community members will serve to disseminate
messages on KMC practices and to facilitate its uptake in the community.
Data Collection A data collection team consisting of 2 members will be instituted for each
implementing tehsils. Their responsibility will be to collect data on the process indicators
weekly for the first 6 weeks and then quarterly till 2 years.
Impact Assessments A midline assessment will be done at all facilities and their catchment
populations in all tehsils after one year of intervention. This midline assessment will serve
to provide us with outcomes and evaluation of the intervention. Results of midline will
identify areas of improvement and re-modeling if needed. A final assessment will be carried
out after the completion of (Facility KMC plus cKMC) intervention in all tehsils. Through
this design we will compare pre and post intervention change in practices at facility level
and at individual level of household. End line assessment will be carried out to estimate
increase in effective coverage of KMC among newborns having birth weight of 2000grams or
less.
Training of Facility and Community Providers This implementation project will be guided by
the experience of our Dadu-KMC project, and we will adopt the contextual insights and the
information, education and counselling material used in the project for parents and families
to create awareness and to explain the benefits of KMC for survival & wellbeing of
low-birth-weight newborns.
Facility Based KMC Facility based Kangaroo Mother Care (KMC) will be practiced at health
facilities, where newborns are delivered or referred. The frontlines workers are health
professional involved in newborn care will be trained such as physicians, nurses, midwives,
technicians and obstetricians at facility level. The training will be conducted over 3-4
days. The content will include the theoretical knowledge as well as teaching the complete set
of skills. Information, Education and Communication material will be used for implementing
KMC at the facility. The IEC material will include messages in the pictorial form on KMC
positioning, nutrition (breast feeding, feeding expressed breast milk or feeding through
nasogastric tube), criteria for discharge, monitoring and assessment during KMC, recognition
of danger sings, referral and follow-up. Recording tools will be adapted and developed to
record the observations when implementing KMC at the facility level. The IEC material is
comprised of flip charts, wall mounts and a self-explanatory video on steps of KMC, its
benefits.
Community Based KMC Community KMC will be practiced at the household levels where newborns
are cared by mother, father and family members. Health Providers from the community such as
LHWs will visit households and assess babies according to the scheduled follow-up visits. At
community level mother, spouse, family members, community leaders, LHVs, LHWs, CHWs, and
TBAs, which will be trained first for community KMC.
Experts from AKU will serve as trainers for KMC and essential newborn care. Educational
material such as information, pictorial booklet, flip charts and video films on KMC in local
language will be made available for the mothers, families, facility providers, LHWs and study
staff. These trainings will be conducted at the field site, through KMC videos and flip
charts. The training routine will consist of 2-day classroom and 2 day real life field
scenario for facility providers. Similarly, the LHW's of the selected facility catchment area
will also be trained to pregnancy surveillance, case referral, notification and follow-ups
and will also be trained to deliver information, education and support for the KMC practices
at the household level in 2 days training workshop by respective facility providers.
