MalnutritionPhase 1iycfchNCT01407224
Assessing Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices
A Phase 1 study testing Improve Early Breastfeeding in people with Malnutrition, run by Eminence at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Improve Early Breastfeeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2010to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Lactating women of children ages 0 to 5 months and pregnant women with second and third trimester
Who cannot join
- First trimester women and lactating women of children ages 6 to 23 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices (Bangladesh)
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Improve Early Breastfeeding
- Keywords
- Exclusive Breastfeeding, Skin to skin contact, Cord Clumping, Prelactial feeding
- Medical subject headings
- Malnutrition, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improve Early BreastfeedingBehavioural
Also called IYCFCH
One arm got only training, another arm training and supervision and third arm without any intervention as control.
| Study group | Role | What they receive |
|---|---|---|
| Only training | Experimental | Training on Early Breastfeeding Practices to front line health workers Receives: Behavioral: Improve Early Breastfeeding |
| Training and supervision | Active comparator | Training as well as supervision by field supervisor for six months intervention Receives: Behavioral: Improve Early Breastfeeding |
| Control | No intervention | No intervention such as training or supervision Receives: Behavioral: Improve Early Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased proportions of mothers who follow the recommended infant feeding behaviors
Practice related to early breastfeeding and cord clumping
Measured: six months intervention
Secondary outcomes (2)
Improve practice on breastfeeding, early initiation and cord clumping .
Evaluation studies are carried out before and after six months of intervention
Measured: six months intervention
Improved capacity of TBAs on breastfeeding counseling and knowledge.
Increase capacity of TBAs on breastfeeding counseling and knowledge.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eminence
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Investigators
- DR. Shamim Talukder, M.Phil, Principal investigator, Eminence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407224
- Sponsor's protocol ID
- 09-000076-AT10,EMI
- Acronym
- iycfch
- Status last verified
- Jul 2011
- First submitted
- 30 Jun 2011
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
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.
PubMed 36282618
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices (Bangladesh)
- ClinicalTrials.gov ID
- NCT01407224
- Acronym / sponsor ID
- iycfch / 09-000076-AT10,EMI
- Conditions
- Malnutrition
- Keywords
- Exclusive Breastfeeding, Skin to skin contact, Cord Clumping, Prelactial feeding
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- EminenceIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Only training | Experimental | Behavioral: Improve Early BreastfeedingTraining on Early Breastfeeding Practices to front line health workers |
| Training and supervision | Active comparator | Behavioral: Improve Early BreastfeedingTraining as well as supervision by field supervisor for six months intervention |
| Control | No intervention | Behavioral: Improve Early BreastfeedingNo intervention such as training or supervision |
Who may qualify
- Ages
- 1 day to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Lactating women of children ages 0 to 5 months and pregnant women with second and third trimester
Key exclusion criteria (1 listed)
- First trimester women and lactating women of children ages 6 to 23 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improve Early BreastfeedingAlso: IYCFCHOne arm got only training, another arm training and supervision and third arm without any intervention as control. | Behavioural | Control, Only training, Training and supervision |
Primary outcome
Increased proportions of mothers who follow the recommended infant feeding behaviors
Time frame: six months intervention
Practice related to early breastfeeding and cord clumping
2 secondary outcomes
Improve practice on breastfeeding, early initiation and cord clumping .
Time frame: six months intervention
Improved capacity of TBAs on breastfeeding counseling and knowledge.
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
- BackgroundDewey 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
- Derived from this study: PubMed 36282618Gavine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR. Shamim Talukder, M.Phil principal investigator
Eminence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Improve Early Breastfeeding in people with Malnutrition, run by Eminence at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased proportions of mothers who follow the recommended infant feeding behaviors (time frame: six months intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011; AzTrials last refreshed its copy on 7 Nov 2026.