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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Nutritional Status
- 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.
Mortality
Morbidity
Secondary outcomes (2)
Time to introduction of water
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.
- First posted19 Aug 2005 (estimated)
- Study startMar 2000
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Investigators
- Peter Aaby, Msc, Principal investigator, Bandim Health Project, Statens Seruminstitut
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspects of Exclusive Breast-Feeding in Guinea Bissau. Intervention Study to Clarify Recommendations for Breast-Feeding Policy in Developing Countries
- ClinicalTrials.gov ID
- NCT00131625
- Acronym / sponsor ID
- 104.dan.8-839-exclbrea
- Conditions
- Nutritional Status
- Keywords
- Exclusive breast-feeding, Mortality, Morbidity, Nutrition, Low income country
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- Mar 2000
- Study completion
- Feb 2002
- First posted
- 19 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Death before 7 days of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education according to WHO recommendations | Behavioural | – |
Primary outcome
Mortality
Morbidity
2 secondary outcomes
Time to introduction of water
Time to introduction of weaning food
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Aaby, Msc principal investigator
Bandim Health Project, Statens Seruminstitut
1 site in 1 country: see every site and its status.
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.