NCT01428232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
992

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 25, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

August 29, 2011

Last Update Submit

April 21, 2017

Conditions

Breastfeeding

Keywords

BreastfeedingBaby Friendly Hospital InitiativeWell-child clinics

Outcome Measures

Primary Outcomes (2)

  • Early initiation of breastfeeding

    initiation of breastfeeding within one hour of birth

    Within 1 hour of birth

  • Exclusive breastfeeding rate

    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 Outcomes (6)

  • Episodes of diarrhea

    in the first 6 months of life

  • Episodes of Lower Respiratory Track Infection

    in the first 6 months of life

  • Partial Breastfeeding rate

    up to 6 months after birth

  • Number of hospitalization

    in the first 6 months of life

  • Number of mothers seeking breastfeeding help

    in the first 6 months of life

  • +1 more secondary outcomes

Study Arms (3)

BFHI steps 1-9

EXPERIMENTAL

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

BFHI steps 1-9 +well-child clinic

EXPERIMENTAL

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

usual care

NO INTERVENTION

Interventions

implementation of the Baby-Friendly Hospital InitiativeOTHER

Implementation of BFHI steps 1-9 in maternities

BFHI steps 1-9
BFHI steps 1-9 +well-child clinicOTHER

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

BFHI steps 1-9 +well-child clinic

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • refusal to participate, not speaking Lingala nor French, unable to breastfeed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ksph/Unc-Drc

Kinshasa, Kinshasa, Republic of the Congo

Location

Related Publications (6)

  • 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.

    PMID: 24083882RESULT

  • 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.

    PMID: 26246225RESULT

  • 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.

    PMID: 28058663RESULT

  • 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.

    PMID: 27549632RESULT

  • 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.

    PMID: 33428617DERIVED

  • 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.

    PMID: 29417366DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2011

First Posted

September 2, 2011

Study Start

May 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 25, 2017

Record last verified: 2017-01

Locations

RE(1)