Clinical trial NCT01407224: Assessing Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices
Official title: Assessing the Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices (Bangladesh)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malnutrition
Keywords: Exclusive Breastfeeding
Skin to skin contact
Cord Clumping
Prelactial feeding
Lead sponsor: Eminence
Sponsor class: INDUSTRY
Collaborators: name: University of California, Davis
First posted: 2011-08-02
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this operational research is to compare the cost-effectiveness of two methods for capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and increase early exclusive breastfeeding in research areas of rural Bangladesh.

Detailed description: Suboptimal early infant feeding practices are the norm in Bangladesh, and contribute to its poor infant health and nutrition. However, the modern health services are unable to help because approximately 85% of births take place at home. The Government has begun the huge process of training the informal community traditional birth attendants (TBAs) who, along with community volunteers (CVs), deliver the majority of babies, especially in the rural areas. The proposed operations research will take place in one of the poorest rural districts. It will compare the cost effectiveness of practical training of these relatively uneducated community members, with or without supportive supervision in improving early infant feeding practices, using a cluster-randomized study design. The practices to be measured before and after on probability samples include: 1) delayed cord clamping, 2) early skin to skin contact and 3) newborn-led initiation of breastfeeding within one hour of birth, 4) avoidance of the traditional prelacteal feeds, and 5) exclusive breastfeeding, at least for the early months. Costs will be carefully monitored so as to compare the cost per behavior improved per infant.

Eligibility criteria: Inclusion Criteria:

* Lactating women of children ages 0 to 5 months and pregnant women with second and third trimester

Exclusion Criteria:

* First trimester women and lactating women of children ages 6 to 23 months.

Primary outcomes:
measure: Increased proportions of mothers who follow the recommended infant feeding behaviors
timeFrame: six months intervention
Secondary outcomes:
measure: Improve practice on breastfeeding, early initiation and cord clumping .
timeFrame: six months intervention
measure: Improved capacity of TBAs on breastfeeding counseling and knowledge.
timeFrame: Six months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Eminence
Study officials:
affiliation: Eminence
name: DR. Shamim Talukder, M.Phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dewey KG,Talukder S, Greiner T, Farhana D, Shajedul H, Haider R. Assessing cost and effectiveness of training and supervision for front line health workers to improve breastfeeding practice The Lancet 330(13):913-919,2011
citation: Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.