NCT00131625

Brief Summary

Exclusive breastfeeding is promoted by the World Health Organization (WHO) with the aim of improving infant health. The specific objective of the study was to examine the effect of exclusive breast-feeding on morbidity and mortality in a randomised prospective study. Children born by mothers recorded as living in the study area during pregnancy was randomised at birth. WHO recommendations to postpone introduction of water and weaning food were told to the mother by 2-weekly home visits. All study children were followed from birth till 1 year of age according to morbidity, hospitalisation and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2000

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
Last Updated

October 10, 2005

Status Verified

August 1, 2005

First QC Date

August 18, 2005

Last Update Submit

October 7, 2005

Conditions

Nutritional Status

Keywords

Exclusive breast-feedingMortalityMorbidityNutritionLow income country

Outcome Measures

Primary Outcomes (2)

  • Mortality

  • Morbidity

Secondary Outcomes (2)

  • Time to introduction of water

  • Time to introduction of weaning food

Interventions

Health education according to WHO recommendationsBEHAVIORAL

Eligibility Criteria

Age0 Years - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children born in the study area in the period 1st March 2000 till 28th February 2001 by mothers recorded as living in the area during pregnancy.

You may not qualify if:

  • Death before 7 days of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project, Apartado 861

Bissau, Guinea-Bissau

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Peter Aaby, Msc

    Bandim Health Project, Statens Seruminstitut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 19, 2005

Study Start

March 1, 2000

Study Completion

February 1, 2002

Last Updated

October 10, 2005

Record last verified: 2005-08

Locations

GU(1)