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

This study has been completed.
Sponsor:
Collaborators:
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)
Ministry of Public Health, Democratic Republic of the Congo
Information provided by (Responsible Party):
Marcel Yotebieng, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01428232
First received: August 29, 2011
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Breastfeeding
Other: implementation of the Baby-Friendly Hospital Initiative
Other: BFHI steps 1-9 +well-child clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Early initiation of breastfeeding [ Time Frame: Within 1 hour of birth ] [ Designated as safety issue: No ]
    initiation of breastfeeding within one hour of birth

  • Exclusive breastfeeding rate [ Time Frame: up to 6 months after birth ] [ Designated as safety issue: No ]
    Infants will be classified as exclusively breastfed if they received only breast milk (no water, other liquids, or solids)


Secondary Outcome Measures:
  • Episodes of diarrhea [ Time Frame: in the first 6 months of life ] [ Designated as safety issue: No ]
  • Episodes of Lower Respiratory Track Infection [ Time Frame: in the first 6 months of life ] [ Designated as safety issue: No ]
  • Partial Breastfeeding rate [ Time Frame: up to 6 months after birth ] [ Designated as safety issue: No ]
  • Number of hospitalization [ Time Frame: in the first 6 months of life ] [ Designated as safety issue: No ]
  • Number of mothers seeking breastfeeding help [ Time Frame: in the first 6 months of life ] [ Designated as safety issue: No ]
  • Amount and type of breastfeeding support given by Health care provider to mothers [ Time Frame: in the first 6 months after birth ] [ Designated as safety issue: No ]

Enrollment: 992
Study Start Date: May 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: usual care

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.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428232

Locations
Congo
Ksph/Unc-Drc
Kinshasa, Congo
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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)
Ministry of Public Health, Democratic Republic of the 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
  More Information

Additional Information:
Publications:
Responsible Party: Marcel Yotebieng, MD, Research Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01428232     History of Changes
Other Study ID Numbers: 09-000076-AT11-123-UNC-DRC
Study First Received: August 29, 2011
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board
Congo, Democratic Republic of the: Kinshasa School of Public Health Ethical Committee

Keywords provided by University of North Carolina, Chapel Hill:
Breastfeeding
Baby Friendly Hospital Initiative
Well-child clinics

ClinicalTrials.gov processed this record on October 19, 2014