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

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428232
• Other study ID #: 09-000076-AT11-123-UNC-DRC
• Status: Completed
• Phase: N/A
• First received: August 29, 2011
• Last updated: April 21, 2017
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 992
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• implementation of the Baby-Friendly Hospital Initiative
Implementation of BFHI steps 1-9 in maternities
• BFHI 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

Locations

Country	Name	City	State
Congo	Ksph/Unc-Drc	Kinshasa

Sponsors (6)

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

Country where clinical trial is conducted

Congo, 

References & Publications (4)

Brazeau 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 — View Citation

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. — View Citation

Yotebieng 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. — View Citation

Zivich 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/s1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early initiation of breastfeeding	initiation of breastfeeding within one hour of birth	Within 1 hour of birth
Primary	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	Episodes of diarrhea		in the first 6 months of life
Secondary	Episodes of Lower Respiratory Track Infection		in the first 6 months of life
Secondary	Partial Breastfeeding rate		up to 6 months after birth
Secondary	Number of hospitalization		in the first 6 months of life
Secondary	Number of mothers seeking breastfeeding help		in the first 6 months of life
Secondary	Amount and type of breastfeeding support given by Health care provider to mothers		in the first 6 months after birth

External Links

•   Carolina Global Breastfeeding Institute