BreastfeedingNCT01428232
Effectiveness of Well-child Clinics as the "Community" Basis of Step 10 of the Baby Friendly Hospital Initiative
A study testing implementation of the Baby-Friendly Hospital Initiative and BFHI steps 1-9 +well-child clinic in people with Breastfeeding, run by University of North Carolina, Chapel Hill at 1 site in Republic of the Congo.
Trial summary
A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo to compare rates of early initiation and exclusive breastfeeding between mothers who give birth in hospitals with the current standard of care, mothers who give birth in hospitals that have implemented the first nine steps of… Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- implementation of the Baby-Friendly Hospital Initiative and BFHI steps 1-9 +well-child clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- May 2012to Feb 2013
- Phase
- Interventional
- 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 Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- mothers of healthy infants being discharged from participating maternities who intend to attend well-baby clinic visits in the same health care facilities until the child will be at least 6 months
Who cannot join
- refusal to participate, not speaking Lingala nor French, unable to breastfeed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Clinic-based Interventions to Promote Early Initiation and Exclusive Breastfeeding Through 6 Months After Birth in Kinshasa, Democratic Republic of Congo
A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo to compare rates of early initiation and exclusive breastfeeding between mothers who give birth in hospitals with the current standard of care, mothers who give birth in hospitals that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly Hospital Initiative, with the 10th step being the provision of breastfeeding support during well-child clinic visits.
Read the detailed description
If at least 90% of children were exclusively breastfed for the first 6-months of life, the potential reduction in mortality that can be achieved will be higher than for any other interventions with sufficient evidence of effect. In the DRC >500,000 under-five deaths occurred in 2008. While >95% of children were breastfed at some point, 18% received something other than breast milk before initiation of breastfeeding, and half received something other than human milk by 1.4 months. Pre- and post-partum breastfeeding support has been shown to best improve the rate of exclusive breastfeeding (EBF). The global initiatives to improve breastfeeding practices have focused on maternity-level policies and procedures known as the Ten Steps to Successful Breastfeeding, which served as the basis for the Baby-Friendly Hospital Initiative. These quality of care steps impact hospital breastfeeding rates as well as breastfeeding rates throughout the 6 months postpartum period. However, EBF rates fall off rapidly in the DRC. In the proposed cluster randomized controlled trial, we plan to evaluate the effect of breastfeeding support provided by well-child clinic staff including the use of culturally appropriate messages in addition to the implementation of BFHI steps 1-9 Steps in maternities on the rate of breastfeeding initiation within 1 hour of birth and EBF throughout 6 months postpartum. If effective, this approach has great potential for scale up where most needed.
- Conditions
- Breastfeeding
- Being tested
- implementation of the Baby-Friendly Hospital Initiative, BFHI steps 1-9 +well-child clinic
- Keywords
- Breastfeeding, Baby Friendly Hospital Initiative, Well-child clinics
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation of the Baby-Friendly Hospital InitiativeOther
Implementation of BFHI steps 1-9 in maternities
BFHI steps 1-9 +well-child clinicOther
Implementation of BFHI steps 1-9 in maternities and provision of breastfeeding support including culturally appropriate educational messages and metaphors as the ongoing aspect of step 10 in well-child clinic
| Study group | Role | What they receive |
|---|---|---|
| BFHI steps 1-9 | Experimental | Hospital retrained in BFHI steps 1-9 Mothers can call hospital to obtain BF support/Mothers given phone # of maternity nurse whom she can call or go see if she has BF problems Receives: Other: implementation of the Baby-Friendly Hospital Initiative |
| BFHI steps 1-9 +well-child clinic | Experimental | Hospital retrained in BFHI steps 1-9 Mothers can call hospital to obtain BF support/Mothers given phone # of maternity nurse whom she can call or go see if she has BF problems Provision of BF support during 1) clinic visit to obtain birth certificate or home visit if mother does not come into clinic and 2) well-child clinics Flyers to mother with culturally appropriate messages designed to address some of the most important local barrier to EBF Receives: Other: BFHI steps 1-9 +well-child clinic |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early initiation of breastfeeding
initiation of breastfeeding within one hour of birth
Measured: Within 1 hour of birth
Exclusive breastfeeding rate
Infants will be classified as exclusively breastfed if they received only breast milk (no water, other liquids, or solids)
Measured: up to 6 months after birth
Secondary outcomes (6)
Episodes of diarrhea
Measured: in the first 6 months of life
Episodes of Lower Respiratory Track Infection
Measured: in the first 6 months of life
Partial Breastfeeding rate
Measured: up to 6 months after birth
Number of hospitalization
Measured: in the first 6 months of life
Number of mothers seeking breastfeeding help
Measured: in the first 6 months of life
Amount and type of breastfeeding support given by Health care provider to mothers
Measured: in the first 6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startMay 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Kinshasa School of Public Health (DR, Congo), Centre for the Coordination of Social Science Research and Documentation in Africa South of the Sahara (CERDAS) (DR,Congo), Bureau Diocésain des Œuvres Médicales de Kinshasa (BDOM), (DR, Congo), Salvation Army (DR, Congo), Ministry of Public Health, Democratic Republic of the Congo
- Responsible party
- Sponsor
- Investigators
- Marcel Yotebieng, M.D, MPH, Ph.D, Principal investigator, University of North Carolina, Chapel HillMiriam Labbok, MD, MPH, FACPM, IBCLC, Principal investigator, University of North Carolina, Chapel HillFrieda Behets, Ph.D, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428232
- Sponsor's protocol ID
- 09-000076-AT11-123-UNC-DRC
- Status last verified
- Jan 2017
- First submitted
- 29 Aug 2011
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Yotebieng M, Chalachala JL, Labbok M, Behets F. Infant feeding practices and determinants of poor breastfeeding behavior in Kinshasa, Democratic Republic of Congo: a descriptive study. Int Breastfeed J. 2013 Oct 1;8(1):11. doi: 10.1186/1746-4358-8-11.
PubMed 24083882Yotebieng M, Labbok M, Soeters HM, Chalachala JL, Lapika B, Vitta BS, Behets F. Ten Steps to Successful Breastfeeding programme to promote early initiation and exclusive breastfeeding in DR Congo: a cluster-randomised controlled trial. Lancet Glob Health. 2015 Sep;3(9):e546-55. doi: 10.1016/S2214-109X(15)00012-1. Epub 2015 Aug 2.
PubMed 26246225Zivich PN, Kiketa L, Kawende B, Lapika B, Yotebieng M. Vaccination Coverage and Timelines Among Children 0-6 Months in Kinshasa, the Democratic Republic of Congo: A Prospective Cohort Study. Matern Child Health J. 2017 May;21(5):1055-1064. doi: 10.1007/s10995-016-2201-z.
PubMed 28058663Brazeau NF, Tabala M, Kiketa L, Kayembe D, Chalachala JL, Kawende B, Lapika B, Meshnick SR, Yotebieng M. Exclusive Breastfeeding and Clinical Malaria Risk in 6-Month-Old Infants: A Cross-Sectional Study from Kinshasa, Democratic Republic of the Congo. Am J Trop Med Hyg. 2016 Oct 5;95(4):827-830. doi: 10.4269/ajtmh.16-0011. Epub 2016 Aug 22.
PubMed 27549632Agler RA, Zivich PN, Kawende B, Behets F, Yotebieng M. Postpartum depressive symptoms following implementation of the 10 steps to successful breastfeeding program in Kinshasa, Democratic Republic of Congo: A cohort study. PLoS Med. 2021 Jan 11;18(1):e1003465. doi: 10.1371/journal.pmed.1003465. eCollection 2021 Jan.
PubMed 33428617Zivich P, Lapika B, Behets F, Yotebieng M. Implementation of Steps 1-9 to Successful Breastfeeding Reduces the Frequency of Mild and Severe Episodes of Diarrhea and Respiratory Tract Infection Among 0-6 Month Infants in Democratic Republic of Congo. Matern Child Health J. 2018 May;22(5):762-771. doi: 10.1007/s10995-018-2446-9.
PubMed 29417366
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Clinic-based Interventions to Promote Early Initiation and Exclusive Breastfeeding Through 6 Months After Birth in Kinshasa, Democratic Republic of Congo
- ClinicalTrials.gov ID
- NCT01428232
- Acronym / sponsor ID
- 09-000076-AT11-123-UNC-DRC
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, Baby Friendly Hospital Initiative, Well-child clinics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Kinshasa School of Public Health (DR, Congo), Centre for the Coordination of Social Science Research and Documentation in Africa South of the Sahara (CERDAS) (DR,Congo), Bureau Diocésain des Œuvres Médicales de Kinshasa (BDOM), (DR, Congo), Salvation Army (DR, Congo), Ministry of Public Health, Democratic Republic of the Congo
- Study start
- May 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Sep 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.
A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo to compare rates of early initiation and exclusive breastfeeding between mothers who give birth in hospitals with the current standard of care, mothers who give birth in hospitals that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly Hospital Initiative, with the 10th step being the provision of breastfeeding support during well-child clinic visits.
Detailed description
If at least 90% of children were exclusively breastfed for the first 6-months of life, the potential reduction in mortality that can be achieved will be higher than for any other interventions with sufficient evidence of effect. In the DRC >500,000 under-five deaths occurred in 2008. While >95% of children were breastfed at some point, 18% received something other than breast milk before initiation of breastfeeding, and half received something other than human milk by 1.4 months. Pre- and post-partum breastfeeding support has been shown to best improve the rate of exclusive breastfeeding (EBF). The global initiatives to improve breastfeeding practices have focused on maternity-level policies and procedures known as the Ten Steps to Successful Breastfeeding, which served as the basis for the Baby-Friendly Hospital Initiative. These quality of care steps impact hospital breastfeeding rates as well as breastfeeding rates throughout the 6 months postpartum period. However, EBF rates fall off rapidly in the DRC. In the proposed cluster randomized controlled trial, we plan to evaluate the effect of breastfeeding support provided by well-child clinic staff including the use of culturally appropriate messages in addition to the implementation of BFHI steps 1-9 Steps in maternities on the rate of breastfeeding initiation within 1 hour of birth and EBF throughout 6 months postpartum. If effective, this approach has great potential for scale up where most needed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BFHI steps 1-9 | Experimental | Other: implementation of the Baby-Friendly Hospital InitiativeHospital retrained in BFHI steps 1-9 Mothers can call hospital to obtain BF support/Mothers given phone # of maternity nurse whom she can call or go see if she has BF problems |
| BFHI steps 1-9 +well-child clinic | Experimental | Other: BFHI steps 1-9 +well-child clinicHospital retrained in BFHI steps 1-9 Mothers can call hospital to obtain BF support/Mothers given phone # of maternity nurse whom she can call or go see if she has BF problems Provision of BF support during 1) clinic visit to obtain birth certificate or home visit if mother does not come into clinic and 2) well-child clinics Flyers to mother with culturally appropriate messages designed to address some of the most important local barrier to EBF |
| usual care | No intervention | – |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- mothers of healthy infants being discharged from participating maternities who intend to attend well-baby clinic visits in the same health care facilities until the child will be at least 6 months
Key exclusion criteria (1 listed)
- refusal to participate, not speaking Lingala nor French, unable to breastfeed
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 |
|---|---|---|
| implementation of the Baby-Friendly Hospital InitiativeImplementation of BFHI steps 1-9 in maternities | Other | BFHI steps 1-9 |
| BFHI steps 1-9 +well-child clinicImplementation of BFHI steps 1-9 in maternities and provision of breastfeeding support including culturally appropriate educational messages and metaphors as the ongoing aspect of step 10 in well-child clinic | Other | BFHI steps 1-9 +well-child clinic |
Primary outcome
Early initiation of breastfeeding
Time frame: Within 1 hour of birth
initiation of breastfeeding within one hour of birth
Exclusive breastfeeding rate
Time frame: up to 6 months after birth
Infants will be classified as exclusively breastfed if they received only breast milk (no water, other liquids, or solids)
6 secondary outcomes
Episodes of diarrhea
Time frame: in the first 6 months of life
Episodes of Lower Respiratory Track Infection
Time frame: in the first 6 months of life
Partial Breastfeeding rate
Time frame: up to 6 months after birth
Number of hospitalization
Time frame: in the first 6 months of life
Number of mothers seeking breastfeeding help
Time frame: in the first 6 months of life
Amount and type of breastfeeding support given by Health care provider to mothers
Time frame: in the first 6 months after birth
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 25 Apr 2017.
- Results publication: PubMed 24083882Yotebieng M, Chalachala JL, Labbok M, Behets F. Infant feeding practices and determinants of poor breastfeeding behavior in Kinshasa, Democratic Republic of Congo: a descriptive study. Int Breastfeed J. 2013 Oct 1;8(1):11. doi: 10.1186/1746-4358-8-11.
- Results publication: PubMed 26246225Yotebieng M, Labbok M, Soeters HM, Chalachala JL, Lapika B, Vitta BS, Behets F. Ten Steps to Successful Breastfeeding programme to promote early initiation and exclusive breastfeeding in DR Congo: a cluster-randomised controlled trial. Lancet Glob Health. 2015 Sep;3(9):e546-55. doi: 10.1016/S2214-109X(15)00012-1. Epub 2015 Aug 2.
- Results publication: PubMed 28058663Zivich PN, Kiketa L, Kawende B, Lapika B, Yotebieng M. Vaccination Coverage and Timelines Among Children 0-6 Months in Kinshasa, the Democratic Republic of Congo: A Prospective Cohort Study. Matern Child Health J. 2017 May;21(5):1055-1064. doi: 10.1007/s10995-016-2201-z.
- Results publication: PubMed 27549632Brazeau NF, Tabala M, Kiketa L, Kayembe D, Chalachala JL, Kawende B, Lapika B, Meshnick SR, Yotebieng M. Exclusive Breastfeeding and Clinical Malaria Risk in 6-Month-Old Infants: A Cross-Sectional Study from Kinshasa, Democratic Republic of the Congo. Am J Trop Med Hyg. 2016 Oct 5;95(4):827-830. doi: 10.4269/ajtmh.16-0011. Epub 2016 Aug 22.
- Derived from this study: PubMed 33428617Agler RA, Zivich PN, Kawende B, Behets F, Yotebieng M. Postpartum depressive symptoms following implementation of the 10 steps to successful breastfeeding program in Kinshasa, Democratic Republic of Congo: A cohort study. PLoS Med. 2021 Jan 11;18(1):e1003465. doi: 10.1371/journal.pmed.1003465. eCollection 2021 Jan.
- Derived from this study: PubMed 29417366Zivich P, Lapika B, Behets F, Yotebieng M. Implementation of Steps 1-9 to Successful Breastfeeding Reduces the Frequency of Mild and Severe Episodes of Diarrhea and Respiratory Tract Infection Among 0-6 Month Infants in Democratic Republic of Congo. Matern Child Health J. 2018 May;22(5):762-771. doi: 10.1007/s10995-018-2446-9.
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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.
Marcel Yotebieng, M.D, MPH, Ph.D principal investigator
University of North Carolina, Chapel Hill
Miriam Labbok, MD, MPH, FACPM, IBCLC principal investigator
University of North Carolina, Chapel Hill
Frieda Behets, Ph.D, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implementation of the Baby-Friendly Hospital Initiative and BFHI steps 1-9 +well-child clinic in people with Breastfeeding, run by University of North Carolina, Chapel Hill at 1 site in Republic of the Congo.
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 25 Apr 2017. 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 Republic of the Congo. 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.
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?
Early initiation of breastfeeding (time frame: Within 1 hour of birth). The study lists 2 primary outcomes in all. 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 NCT01428232, which also lists 6 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 25 Apr 2017.