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

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Other: implementation of the Baby-Friendly Hospital Initiative; Other: BFHI steps 1-9 +well-child clinic

• Registration Number: NCT01428232
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Study Start: 2012-05
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 992

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BFHI steps 1-9	implementation of the Baby-Friendly Hospital Initiative	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
BFHI steps 1-9 +well-child clinic	BFHI steps 1-9 +well-child clinic	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

Primary Outcome Measures

Name	Time	Method
Early initiation of breastfeeding	Within 1 hour of birth	initiation of breastfeeding within one hour of birth
Exclusive breastfeeding rate	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)

Secondary Outcome Measures

Name	Time	Method
Partial Breastfeeding rate	up to 6 months after birth
Number of hospitalization	in the first 6 months of life
Episodes of diarrhea	in the first 6 months of life
Episodes of Lower Respiratory Track Infection	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

Trial Locations

Locations (1)

Ksph/Unc-Drc; 🇨🇬 Kinshasa, Congo