Skip to main content
OpenTrials
Completed

NCT Number: NCT01428232

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ksph/Unc-Drc

Kinshasa, Republic of the Congo

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

implementation of the Baby-Friendly Hospital Initiative

Other

Implementation of BFHI steps 1-9 in maternities

BFHI steps 1-9 +well-child clinic

Other

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

Primary outcomes

  1. Early initiation of breastfeeding

    Time frame: Within 1 hour of birth

    initiation of breastfeeding within one hour of birth

  2. 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)

Secondary outcomes

  1. Episodes of diarrhea

    Time frame: in the first 6 months of life

  2. Episodes of Lower Respiratory Track Infection

    Time frame: in the first 6 months of life

  3. Partial Breastfeeding rate

    Time frame: up to 6 months after birth

  4. Number of hospitalization

    Time frame: in the first 6 months of life

  5. Number of mothers seeking breastfeeding help

    Time frame: in the first 6 months of life

  6. Amount and type of breastfeeding support given by Health care provider to mothers

    Time frame: in the first 6 months after birth

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • 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)

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 2, 2011
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.