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

April 21, 2017 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

992

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Congo
      • Kinshasa, Congo
        • Ksph/Unc-Drc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: usual care
EXPERIMENTAL: BFHI steps 1-9
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
Implementation of BFHI steps 1-9 in maternities
EXPERIMENTAL: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early initiation of breastfeeding
Time Frame: Within 1 hour of birth
initiation of breastfeeding within one hour of birth
Within 1 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)
up to 6 months after birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Episodes of diarrhea
Time Frame: in the first 6 months of life
in the first 6 months of life
Episodes of Lower Respiratory Track Infection
Time Frame: in the first 6 months of life
in the first 6 months of life
Partial Breastfeeding rate
Time Frame: up to 6 months after birth
up to 6 months after birth
Number of hospitalization
Time Frame: in the first 6 months of life
in the first 6 months of life
Number of mothers seeking breastfeeding help
Time Frame: in the first 6 months of life
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
in the first 6 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Ministry of Public Health, Democratic Republic of the Congo
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)

Investigators

  • Principal Investigator: Marcel Yotebieng, M.D, MPH, Ph.D, University of North Carolina, Chapel Hill
  • Principal Investigator: Miriam Labbok, MD, MPH, FACPM, IBCLC, University of North Carolina, Chapel Hill
  • Principal Investigator: Frieda Behets, Ph.D, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

August 29, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (ESTIMATE)

September 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09-000076-AT11-123-UNC-DRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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