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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: implementation of the Baby-Friendly Hospital Initiative
* Other: BFHI steps 1-9 +well-child clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFHI steps 1-9<br>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 | Other: implementation of the Baby-Friendly Hospital Initiative<br>* Implementation of BFHI steps 1-9 in maternities<br>|
| Experimental: BFHI steps 1-9 +well-child clinic<br>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 | Other: BFHI steps 1-9 +well-child clinic<br>* 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<br>|
| No Intervention: usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early initiation of breastfeeding | initiation of breastfeeding within one hour of birth | 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) | up to 6 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of diarrhea |  | in the first 6 months of life | 
| Episodes of Lower Respiratory Track Infection |  | in the first 6 months of life | 
| Partial Breastfeeding rate |  | up to 6 months after birth | 
| Number of hospitalization |  | in the first 6 months of life | 
| Number of mothers seeking breastfeeding help |  | in the first 6 months of life | 
| Amount and type of breastfeeding support given by Health care provider to mothers |  | in the first 6 months after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Baby Friendly Hospital Initiative, Well-child clinics