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| Name | Class |
|---|---|
| Murdoch Childrens Research Institute | OTHER |
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The prevalence of asthma and allergic diseases is increasing worldwide. Infections and vaccinations in childhood may have an impact on the subsequent development of asthma and allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Guérin (BCG) vaccine was associated with reduction in atopy. Since then the investigators have conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The present study aims to follow up children enrolled in the BCG randomised trial to assess for asthma and allergy later in childhood. Based on previous observations, the investigators expect children allocated to receive BCG at birth will have a reduction in allergy profile when compared to children who did not receive BCG at birth.
Background: Prevalence of asthma and allergy is increasing worldwide, and the cause is unclear. Previous work by the Bandim Health Project and others has identified that infections and routine childhood vaccinations have an impact on the development of atopic sensitisation and allergic symptoms later in life. A number of these studies have found association between BCG vaccination and reduction in atopy and allergy. Only one randomised trial has been conducted of BCG vaccine to protect against allergy with inconclusive results. The present project provides the opportunity to follow-up children born low birth-weight who were randomised to receive BCG vaccine at birth or to receive BCG later in infancy as part of regular care.
Hypothesis:
Objectives:
Methods: children previously enrolled in NCT00146302 will followed up at home (currently aged 3-9 years) and tested for atopic sensitisation with skin-prick tests and presence of allergic symptoms determined by questionnaire.
Sample size: 812 children from the Bandim Health Project study area were enrolled in the randomised trial. The investigators anticipate to be able to follow up approximately 487 of these children, which will have the power to detect a 30% difference in atopic sensitisation between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low birth-weight cohort | Children previously enrolled in randomised trial NCT00146302 who are currently living within the Bandim Health Project study area |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin prick test | Skin prick tests to common aero and food allergen | Single observation at time of consent - DAY 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of asthma | Symptoms of asthma using questions modified from ISAAC | Single observation at time of consent - DAY 1 |
| Symptoms of eczema | Eczema symptoms using questions modified from ISAAC |
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Inclusion Criteria:
Exclusion Criteria:
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Children previously enrolled in NCT00146302 living within Bandim Health Project study area, Bissau
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| Name | Affiliation | Role |
|---|---|---|
| Peter Aaby, DMSc | Bandim Health Project | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bandim Health Project | Bandim | Guinea-Bissau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23991838 | Derived | Kiraly N, Benn CS, Biering-Sorensen S, Rodrigues A, Jensen KJ, Ravn H, Allen KJ, Aaby P. Vitamin A supplementation and BCG vaccination at birth may affect atopy in childhood: long-term follow-up of a randomized controlled trial. Allergy. 2013 Sep;68(9):1168-76. doi: 10.1111/all.12216. Epub 2013 Aug 31. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004485 | Eczema |
| D005512 | Food Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Faecal samples are collected for analyses of parasites and microbes
| Single observation at time of consent - DAY 1 |
| Symptoms of food allergy | Symptoms of food allergy using questions modified from the Health Nuts study | Single observation at time of consent - DAY 1 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |