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Nutritional StatusPhase 4NCT00131625

Impact of Exclusive Breast-Feeding in Guinea Bissau

A Phase 4 study testing Health education according to WHO recommendations in people with Nutritional Status, run by Bandim Health Project at 1 site in Guinea-Bissau.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 years to 6 months
Conditions the study is for
Nutritional Status
What is being tested?
Health education according to WHO recommendations
How many people
1,500 participants
Where
1 siteGuinea-Bissau
Study dates
Mar 2000to Feb 2002
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years to 6 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Death before 7 days of age

Trial locations and contacts

1 site in 1 country.

Guinea-Bissau1 site
  • Bandim Health Project, Apartado 861

    Bissau

Other trials in Guinea-Bissau

About this study

Official title: Aspects of Exclusive Breast-Feeding in Guinea Bissau. Intervention Study to Clarify Recommendations for Breast-Feeding Policy in Developing Countries

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.

Read the detailed description

Examine in a randomised trial whether postponing of introduction of water and weaning food as recommended by WHO reduces infant morbidity and mortality. Results obtained from observational studies are likely to be due to reverse causality as the mother her self chooses when to introduce water and weaning food. Only a few randomised studies have examined the effect on infant morbidity, and no study has investigated the impact on infant mortality in a low-income country. The study was conducted at Bandim Health Project (BHP) which has conducted a demographic health surveillance system since 1978. Mothers and children were identified by the BHP routine registration. All children born between March 1 2000 until February 28th 2001 in the study area and whose mothers were recorded as living in the area during pregnancy were eligible for inclusion. Children who died within 7 days of birth were excluded in order to avoid birth related morbidity and mortality leaving a total of 1300 children for the study. At birth all children were allocated to an intervention group or a control group. All mother and child pairs were visited bi-weekly by a local, special trained health worker. By individual health education the mothers were motivated to delay introduction of water and weaning food to 6 months of age according to recommendations given by WHO. All mother and child pairs in the control group were visited by the same health assistant. By these visits only information on feeding status was obtained and no intervention given. Further more all study children were followed by assistants blinded to the randomisation with: bi-weekly diarrhoea morbidity interview, monthly anthropometry, including weight, height and arm circumference. All children were followed up to 12 months of age. Demographic as well as socio-economic data, data on hospitalisation, deaths and migrations were obtained from the BHP routine registration system. These data will be collected until the age of 3 years of the child.

Being tested
Health education according to WHO recommendations
Keywords
Exclusive breast-feeding, Mortality, Morbidity, Nutrition, Low income country
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health education according to WHO recommendationsBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

  2. Morbidity

Secondary outcomes (2)
  1. Time to introduction of water

  2. Time to introduction of weaning food

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2005 (estimated)
  2. Study startMar 2000
  3. Study completionFeb 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00131625
Sponsor's protocol ID
104.dan.8-839-exclbrea
Other IDs
104.dan.8-839
Status last verified
Aug 2005
First submitted
18 Aug 2005
Last updated
10 Oct 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Health education according to WHO recommendations in people with Nutritional Status, run by Bandim Health Project at 1 site in Guinea-Bissau.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2005.

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