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

NCT ID: NCT01428232

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

992 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

implementation of the Baby-Friendly Hospital Initiative

Intervention Type OTHER

Implementation of BFHI steps 1-9 in maternities

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

Group Type EXPERIMENTAL

BFHI steps 1-9 +well-child clinic

Intervention Type 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

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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implementation of the Baby-Friendly Hospital Initiative

Implementation of BFHI steps 1-9 in maternities

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kinshasa School of Public Health (DR, Congo)

UNKNOWN

Sponsor Role collaborator

Centre for the Coordination of Social Science Research and Documentation in Africa South of the Sahara (CERDAS) (DR,Congo)

UNKNOWN

Sponsor Role collaborator

Bureau Diocésain des Œuvres Médicales de Kinshasa (BDOM), (DR, Congo)

UNKNOWN

Sponsor Role collaborator

Salvation Army (DR, Congo)

UNKNOWN

Sponsor Role collaborator

Ministry of Public Health, Democratic Republic of the Congo

OTHER_GOV

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcel Yotebieng, M.D, MPH, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Miriam Labbok, MD, MPH, FACPM, IBCLC

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Frieda Behets, Ph.D, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Ksph/Unc-Drc

Kinshasa, Kinshasa, Republic of the Congo

Site Status

Countries

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Republic of the Congo

References

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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.

Reference Type RESULT
PMID: 24083882 (View on PubMed)

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. 2015 Sep;3(9):e546-55. doi: 10.1016/S2214-109X(15)00012-1. Epub 2015 Aug 2.

Reference Type RESULT
PMID: 26246225 (View on PubMed)

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/s10995-016-2201-z.

Reference Type RESULT
PMID: 28058663 (View on PubMed)

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 J Trop Med Hyg. 2016 Oct 5;95(4):827-830. doi: 10.4269/ajtmh.16-0011. Epub 2016 Aug 22.

Reference Type RESULT
PMID: 27549632 (View on PubMed)

Agler RA, Zivich PN, Kawende B, Behets F, Yotebieng M. Postpartum depressive symptoms following implementation of the 10 steps to successful breastfeeding program in Kinshasa, Democratic Republic of Congo: A cohort study. PLoS Med. 2021 Jan 11;18(1):e1003465. doi: 10.1371/journal.pmed.1003465. eCollection 2021 Jan.

Reference Type DERIVED
PMID: 33428617 (View on PubMed)

Zivich P, Lapika B, Behets F, Yotebieng M. Implementation of Steps 1-9 to Successful Breastfeeding Reduces the Frequency of Mild and Severe Episodes of Diarrhea and Respiratory Tract Infection Among 0-6 Month Infants in Democratic Republic of Congo. Matern Child Health J. 2018 May;22(5):762-771. doi: 10.1007/s10995-018-2446-9.

Reference Type DERIVED
PMID: 29417366 (View on PubMed)

Other Identifiers

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09-000076-AT11-123-UNC-DRC

Identifier Type: -

Identifier Source: org_study_id

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