Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT01428232
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2011-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Well-child Clinics as the "Community" Basis of Step 10 of the Baby Friendly Hospital Initiative
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: