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Effectiveness of Well-child Clinics as the Community Basis of Step 10 of the Baby Friendly Hospital Initiative

Comparison of Two Clinic-based Interventions to Promote Early Initiation and Exclusive Breastfeeding Through 6 Months After Birth in Kinshasa, Democratic Republic of Congo

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01428232
Enrollment
992
Registered
2011-09-02
Start date
2012-05-31
Completion date
2013-02-28
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

Breastfeeding, Baby Friendly Hospital Initiative, Well-child clinics

Brief 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 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.

Interventions

OTHERimplementation of the Baby-Friendly Hospital Initiative

Implementation of BFHI steps 1-9 in maternities

OTHERBFHI steps 1-9 +well-child clinic

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

Sponsors

Kinshasa School of Public Health (DR, Congo)
CollaboratorUNKNOWN
Centre for the Coordination of Social Science Research and Documentation in Africa South of the Sahara (CERDAS) (DR,Congo)
CollaboratorUNKNOWN
Bureau Diocésain des Œuvres Médicales de Kinshasa (BDOM), (DR, Congo)
CollaboratorUNKNOWN
Salvation Army (DR, Congo)
CollaboratorUNKNOWN
Ministry of Public Health, Democratic Republic of the Congo
CollaboratorOTHER_GOV
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* refusal to participate, not speaking Lingala nor French, unable to breastfeed

Design outcomes

Primary

MeasureTime frameDescription
Early initiation of breastfeedingWithin 1 hour of birthinitiation of breastfeeding within one hour of birth
Exclusive breastfeeding rateup to 6 months after birthInfants will be classified as exclusively breastfed if they received only breast milk (no water, other liquids, or solids)

Secondary

MeasureTime frame
Partial Breastfeeding rateup to 6 months after birth
Number of hospitalizationin the first 6 months of life
Episodes of diarrheain the first 6 months of life
Amount and type of breastfeeding support given by Health care provider to mothersin the first 6 months after birth
Number of mothers seeking breastfeeding helpin the first 6 months of life
Episodes of Lower Respiratory Track Infectionin the first 6 months of life

Countries

Republic of the Congo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026