CAPS (Childhood asthma prevention study)
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Estudio primario

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The childhood asthma prevention study (CAPS): design and research protocol of a randomized trial for the primary prevention of asthma.

Revista Controlled clinical trials
Año 2001
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The Childhood Asthma Prevention Study is a randomized controlled trial to measure whether the incidence of atopy and asthma can be reduced by house dust mite allergen reduction, a diet supplemented with omega-3 fatty acids, or a combination of both interventions. Six hundred and sixteen pregnant women whose unborn children were at high risk of developing asthma because of a family history were randomized prenatally. Study groups are as follows: Group A (placebo diet intervention, no house dust mite reduction), Group B (placebo diet intervention, active house dust mite reduction), Group C (active diet intervention, no house dust mite reduction), and Group D (active diet intervention, active house dust mite reduction). The house dust mite reduction intervention comprises use of physical and chemical methods to reduce allergen contact. The dietary intervention comprises use of a daily oil supplement from 6 months or at onset of bottle-feeding, and use of margarine and cooking oils based on sunflower or canola oils to increase omega-3 dietary intake. Data is collected quarterly until the infant is 1 year old and then half yearly until age 5 years. Questionnaires are used to collect respiratory illness history and information about diet and home environment. Dust is collected from the child's bed and bedroom and playroom floors. Blinded assessments are conducted at 18 months, 3 years, and 5 years. Skin prick tests to common allergens, blood tests, and detailed illness, medication use, and vaccination histories are collected. Primary outcomes will be the development of allergic sensitization and the presence and severity of asthma. This study is designed to measure the effectiveness of allergen reduction and dietary supplementation, both separately and in combination, for the primary prevention of atopy and asthma. The results of this study may have important implications for public health policies to reduce the incidence of childhood asthma. Control Clin Trials 2001;22:333-354

Estudio primario

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Dieciocho meses de resultados de evitación de ácaros y modificación de la dieta de ácidos grasos en el Estudio de Prevención del Asma infantil (CAPS).

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Revista The Journal of allergy and clinical immunology
Año 2003
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ANTECEDENTES: Los estudios observacionales han relacionado ácaros del polvo doméstico (HDM) de exposición e ingesta dietética de ácidos grasos con asma en la infancia. Sin embargo, la prueba definitiva de su papel en la etiología del asma requiere un ensayo controlado aleatorizado. OBJETIVO: La hipótesis de que la incidencia de asma y alergia en niños de alto riesgo se reduciría en evitación de alergenos HDM, la suplementación con ácidos grasos omega-3 los ácidos grasos, o la combinación de estas estrategias. Se presentan los resultados de un análisis de los resultados provisionales de informes evaluados a los 18 meses. MÉTODOS: Un total de 616 mujeres embarazadas fueron asignados al azar a una intervención evitación HDM, que comprende el uso de fundas de colchón impermeables y un acaricida o el control y el uso de un suplemento de aceite, margarinas y aceites de cocina que contienen altos niveles de ácidos grasos omega-3 los ácidos grasos o control. Estado atópico se determinó mediante pruebas de punción cutánea. Los síntomas, diagnósticos, medicamentos e historias fueron obtenidas a través de entrevistas con los padres. Resultados: La intervención de la dieta resultó en una reducción absoluta del 9,8% (95% CI, 1.5-18.1, p = .02) en la prevalencia de cualquier sibilancias y una reducción absoluta del 7,8% (95% CI, 0.5-15.1, p =. 04) en la prevalencia de sibilancias de> 1 semana, pero no tuvo efecto sobre la IgE sérica, atopia o el diagnóstico de los médicos de asma. La intervención evitación HDM no afectó a estos resultados, pero se asoció con un menor uso de esteroides orales. Conclusión: El aumento de los ácidos grasos omega-3 podrían tener un efecto beneficioso sobre la prevalencia de sibilancias durante los primeros 18 meses de vida. Seguimiento de la edad de 5 años, cuando el efecto de las intervenciones sobre el riesgo de asma se evaluarán, está en marcha.

Estudio primario

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Effectiveness of an intervention to reduce house dust mite allergen levels in children's beds.

Revista Allergy
Año 2003
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BACKGROUND: In temperate climates, exposure to house dust mite (HDM) allergens is the strongest environmental risk factor for childhood asthma. Environmental modifications to limit exposure have the potential to reduce the prevalence of asthma. The aim of this study was to reduce allergen exposure for children at high risk of developing asthma. METHODS: A total of 616 pregnant women were randomized to HDM intervention and control groups. The control group had no special recommendations whereas the intervention group was given allergen impermeable mattress covers and an acaricidal washing detergent for bedding. Children were visited regularly until 18 months of age to have dust collected from their bed. RESULTS: Der p 1 concentrations in the control group increased from 5.20 microg/g at 1 month to 22.18 microg/g at 18 months but remained low in the intervention group, ranging from 3.27 microg/g at 1 month to 6.12 microg/g at 18 months. CONCLUSIONS: In a high HDM allergen environment, a combined approach using physical barriers and an acaricidal wash, is effective in reducing HDM allergen concentrations in bedding. However, even with these control measures in place, HDM allergen levels remained high by international standards.

Estudio primario

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Effect of omega-3 fatty acid concentrations in plasma on symptoms of asthma at 18 months of age.

Revista Pediatric allergy and immunology
Año 2004
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The objective of this study was to assess the relation between observed levels of omega-3 fatty acids in plasma and symptoms of asthma and atopy in children at 18 months of age. A total of 616 women at risk of having a child who would develop asthma because of a family history were recruited from the antenatal clinics of six hospitals in Sydney, Australia. Families were randomized to either active omega-3 supplemented or control group. The active group received a daily tuna fish oil supplement and omega-3-rich margarines and cooking oils and the control group received a placebo supplement with polyunsaturated margarines and cooking oils. When the children were 18 months of age an assessment of symptoms was carried out by a research nurse blinded to treatment group allocation. Atopy was measured by skin prick tests, blood was collected to determine serum immunoglobulin E (IgE), and plasma fatty acid concentrations. A total of 376 children (61.0% of total recruited) completed an assessment at 18 months and had blood taken to determine plasma fatty acid concentrations. Omega-3 fatty acid levels were expressed in quintiles of exposure 'as treated' without reference to treatment group allocation. Wheeze ever, doctor visits for wheeze, bronchodilator use and nocturnal coughing were significantly reduced in children in the higher exposure quintiles. Serum IgE was reduced in the highest quintile but not significantly so. There was no difference in diagnosed asthma or atopy between the exposure quintiles. Although wheeze at this age may not be a good indicator of asthma in later childhood, it is encouraging that some symptoms have been reduced in children with high omega-3 fatty acid concentrations in plasma.

Estudio primario

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Tres-año resultados de las modificación de la dieta de ácidos grasos y polvo de la casa la reducción de ácaro del en el Estudio de la Niñez Prevención del Asma.

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Revista The Journal of allergy and clinical immunology
Año 2004
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ANTECEDENTES: Dos factores que se cree para influir en el riesgo de el asma son el efecto la promoción de de la sensibilización a los ácaros del del polvo doméstico y el efecto preventivo de la aumento de ácidos grasos omega-3 los ácidos grasos. A pesar de polvo de la casa ácaro del la evitación del alergeno se ha utilizado como una estrategia preventiva en los ensayos varios, el efecto de ácidos grasos omega-3 suplementos de ácidos grasos en el prevención primaria de la el asma y la la enfermedad de alérgica no se conoce. OBJETIVO: Para medir los efectos de la los suplementos dietéticos con omega-3 los ácidos grasos y polvo de la casa ácaro del la evitación del alergeno en los niños con una historia familiar de el asma. MÉTODOS: Un total de 616 los niños en situación de riesgo de alta de la el asma estaban matriculados antes del parto en un ensayo controlado estudio aleatorizado, y la 526 niños del se mantuvo en el juicio a la edad de 3 años. Las medidas de resultado fueron los síntomas de la enfermedad de alérgica y sensibilización a alérgenos. RESULTADOS: Se constató un reducción significativa de 10,0% (95% IC del, 3,7-16,4) en la prevalencia de la la tos en los los niños atópicos en el grupo de la dieta activa (P = .003; número necesario a tratar, 10), pero una% insignificante 1,1 ( IC del 95%, -7,1 a 9,5) la tos la reducción de entre los niños no atópicos. Hubo una reducción 7,2% (95% IC del, 10,11 hasta 14.3) en la sensibilización a los ácaros del polvo de la casa en el grupo de alergeno la evitación activa de (P = .05; número necesario a tratar, 14). No se observaron diferencias significativas en la sibilancias fueron encontrados con ya sea la intervención. CONCLUSIÓN: Estos resultados sugieren que nuestras intervenciones, diseñados para ser utilizado en simples campañas de salud pública, pueden tener un papel en la prevención de el desarrollo de la la sensibilización alérgica y la enfermedad de las vías respiratorias en la primera infancia. Este ofrece la perspectiva de la reducción de la enfermedad de alérgica en la vida más tarde.

Estudio primario

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Prevención del asma durante los primeros 5 años de vida: un ensayo controlado aleatorio.

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Revista The Journal of allergy and clinical immunology
Año 2006
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ANTECEDENTES: Las exposiciones iniciales de la vida puede ser importante en el desarrollo de asma y enfermedades alérgicas. OBJETIVO: Probar ácaros del polvo doméstico (HDM) y la evitación de modificación de la dieta de ácidos grasos, implementado durante los primeros 5 años de vida, como las intervenciones para prevenir el asma y las enfermedades alérgicas. MÉTODOS: Se reclutaron recién nacidos con antecedentes familiares de asma antes del parto y al azar que, por separado, para evitar HDM o el control y modificación de la dieta o el control. A la edad de 5 años, fueron evaluados para el asma y el eczema y tenía pruebas cutáneas de la atopia. RESULTADOS: De los 616 niños asignados al azar, 516 (84%) fueron evaluados a la edad de 5 años. La intervención de evitar HDM resultó en una reducción del 61% en las concentraciones de alergenos HDM (ug / g de polvo) en la cama del niño, pero ninguna diferencia en la prevalencia de asma, sibilancias, o atopia (p> 0.1). La prevalencia de eczema fue mayor en el grupo de evitación activa de HDM (26% frente al 19%, p = .06). La proporción de ácidos grasos omega-6 y omega-3 los ácidos grasos en el plasma fue menor en el grupo de la dieta activa (5,8 vs 7,4, p <0,0001). Sin embargo, la prevalencia de asma, sibilancias, eczema, o atopia no difirió entre los grupos de dieta (P> 0,1). CONCLUSIÓN: Se requiere más investigación para establecer si las intervenciones de otros puede ser recomendado para la prevención del asma y enfermedades alérgicas. Implicaciones clínicas: Casa de polvo medidas para evitar los ácaros y la modificación de la dieta de ácidos grasos, tal como se aplica en este ensayo durante la infancia y la primera infancia, no impidió la aparición de asma, eccema o la atopia en niños de alto riesgo.

Estudio primario

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Omega-3 and omega-6 fatty acid exposure from early life does not affect atopy and asthma at age 5 years.

Revista The Journal of allergy and clinical immunology
Año 2007
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BACKGROUND: The Childhood Asthma Prevention Study was a randomized controlled trial conducted in children with a family history of asthma in whom omega-3 fatty acid supplementation and restriction of dietary omega-6 fatty acids did not prevent asthma, eczema, or atopy at age 5 years. OBJECTIVE: We sought to examine the relation of all measures of omega-3 and omega-6 polyunsaturated fatty acids with outcomes at age 5 years in the whole birth cohort, regardless of randomization group. METHODS: Plasma fatty acids were measured at 18 months, 3 years, and 5 years. Compliance with the fatty acid supplements was estimated every 6 months. Dietary intake was assessed at 18 months by means of weighed-food record and at 3 years by means of food-frequency questionnaire. At age 5 years, 516 children were examined for wheeze and eczema (questionnaire) and atopy (skin prick tests, n = 488). Multiple logistic regression was used to evaluate associations between exposures and outcomes. RESULTS: Plasma levels of omega-3 or omega-6 fatty acids were not associated with wheeze, eczema, or atopy at age 5 years (P = .11-.96). Overall, fatty acid exposure, measured as plasma levels, dietary intake, and compliance with supplements, was not associated with any respiratory or allergic outcomes (P = .35-.59). CONCLUSION: This observational analysis of the cohort, using the full range of observed variation in omega-3 and omega-6 fatty acid exposure, supports the negative findings of the randomized controlled trial. CLINICAL IMPLICATIONS: Modification of dietary polyunsaturated fatty acids in early childhood is not helpful in preventing atopy and asthma.

Estudio primario

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Seasonal trends in house dust mite allergen in children's beds over a 7-year period.

Revista Allergy
Año 2007
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BACKGROUND: House dust mite (HDM) allergy is closely linked to the expression of asthma and other allergic diseases. Understanding factors influencing variation in allergen may help in controlling allergic disease. The objective of this study was to investigate the effects of seasonal changes in climate, type of bed used in very early childhood and anti-mite interventions on HDM allergen concentration. METHODS: Participants were enrolled in a randomized-controlled trial of HDM avoidance. Der p 1 was measured in dust samples from children's beds on 13 occasions, from birth to age 5 years, between 1997 and 2004. Bed types were categorized as bassinette, cot or bed. The effects of study month, type of bed and intervention group on HDM allergen concentration were estimated by multiple linear regression. The relation between climatic variables and HDM allergen concentration was investigated using a polynomial distributed lag model. RESULTS: House dust mite allergen concentrations were initially low in cots and bassinettes in 1997/1998, peaked in bassinettes and beds between 1999 and 2001 and then slowly declined during the period 2002/2004. Seasonal fluctuations occurred with minima in summer and two- to threefold higher maxima during late autumn. Allergen peaks were correlated with relative humidity peaks 2 months previously. Seasonal changes in allergen were not affected by the HDM avoidance intervention. CONCLUSIONS: House dust mite allergen concentrations in Sydney beds fluctuate approximately two- to threefold on an annual cycle, partly determined by relative humidity, with peaks in late autumn and minima in summer. Fluctuations of this magnitude might be sufficient to influence asthma symptoms.

Estudio primario

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Adherence to allergy prevention recommendations in children with a family history of asthma.

Revista Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology
Año 2008
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Allergen avoidance has been a major component of most programs for primary prevention of asthma and allergic diseases in childhood. As a part of the Childhood Asthma Prevention Study, families were provided with written and oral information on measures considered to be helpful in the primary prevention of allergic disease in high-risk infants. Dietary measures included advice to breastfeed for 6 months or longer, to delay the introduction of solid foods until after the infant turned 6 months of age, and to delay giving allergenic foods (egg and peanut butter) until after 12 months of age. In the active group of the randomized controlled trial aimed at reducing house dust mite (HDM) allergen levels, parents were advised to use an HDM-impermeable study mattress cover and an acaricide, to avoid sheep skins, and not to use a pillow before 12 months of age. Families received regular visits from the research nurses at 1, 3, 6, 9 and 12 months and phone calls every 6 wk. Only 43.4% of mothers were breastfeeding by 6 months and less than 20% by 12 months. The introduction of solid foods before 6 months was common, 26% by 3 months and 96% by 6 months. Adherence to infant-feeding recommendations was significantly greater in women over 30 yr of age, women who did not smoke during pregnancy, and women who had a tertiary education. Adherence to HDM reduction measures was greater than to those for infant feeding. The presence of symptoms in the form of an itchy rash by 4 wk did not significantly increase adherence. Complete adherence to infant-feeding recommendations in this intervention study of high-risk infants was low despite the provision of written information and reinforcement at home visits. In considering allergy prevention advice offered during clinical care, the likelihood of adherence is a factor which needs to be evaluated in assessing any potential benefits of allergy prevention regimens.

Estudio primario

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Effect of omega 3 and omega 6 fatty acid intakes from diet and supplements on plasma fatty acid levels in the first 3 years of life.

Revista Asia Pacific journal of clinical nutrition
Año 2008
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BACKGROUND: The optimal method for conducting omega (n-)3 polyunsaturated fatty acid (PUFA) supplementation trials in children is unknown. AIM: To assess the impact of n-3 and n-6 PUFA intake from the background diet on plasma levels of n-3 and n-6 PUFA in children aged 0-3 years, with and without n-3 supplementation. METHODS: Subjects were randomised antenatally to receive either n-3 PUFA supplements and low n-6 PUFA cooking oils and spreads or a control intervention, designed to maintain usual fatty acid intake. Dietary intake was assessed at 18 months by 3-day weighed food record and at 3 years by food frequency questionnaire. Plasma phospholipids were measured at both time points. Associations were tested by regression. RESULTS: N-3 PUFA intake from background diet did not significantly affect plasma n-3 levels. In contrast, n-6 PUFA intake in background diet was positively related to plasma n-6 levels in both study groups. In addition, n-6 PUFA intake from diet was negatively associated with plasma n-3 levels at 18 months and 3 years (-0.16%/g n-6 intake, 95%CI -0.29 to -0.03 and -0.05%/g n-6 intake, 95%CI -0.09 to -0.01, respectively) in the active group, but not in the control group. CONCLUSION: Interventions intending to increase plasma n-3 PUFA in children by n-3 supplementation should also minimise n-6 PUFA intake in the background diet.

Estudio primario

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Dietary supplementation with n-3 polyunsaturated fatty acids in early childhood: Effects on blood pressure and arterial structure and function at age 8 y

Revista The American journal of clinical nutrition
Año 2009
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Background: n-3 Fatty acid supplementation in adults results in cardiovascular benefits. However, the cardiovascular effects of n-3 supplementation in early childhood are unknown. Objective: The objective was to evaluate blood pressure (BP) and arterial structure and function in 8-y-old children who had participated in a randomized controlled trial of dietary n-3 and n-6 modification over the first 5 y of life. Design: The children (n = 616; 49% girls) were randomly assigned antenatally to active (n = 312; increase in n-3 intake and decrease in n-6 intake) or control (n = 304) diet interventions implemented from the time of weaning or introduction of solids until 5 y of age. At age 8.0 ± 0.1 y, BP, carotid intima-media thickness, carotid artery distensibility, augmentation index, and brachial pulse wave velocity were measured in 405 of these children. Venous blood was collected for measurement of plasma fatty acids, lipoproteins, high-sensitivity C-reactive protein, and asymmetric dimethylarginine. Plasma fatty acid concentrations were also assessed during the intervention. Results: Plasma concentrations of n-3 fatty acids were higher and of n-6 were lower in the active than in the control diet group at 18 mo and 3 and 5 y (P < 0.0001). Concentrations of n-3 and n-6 fatty acids were similar at 8 y. At 8 y of age, no significant differences were found in BP, carotid intima-media thickness, carotid artery distensibility, augmentation index, asymmetric dimethylarginine, high-sensitivity C-reactive protein, or lipoproteins between diet groups. Conclusion: A dietary supplement intervention to increase n-3 and decrease n-6 intakes from infancy until 5 y does not result in significant improvements in arterial structure and function at age 8 y. This trial was registered at the Australian Clinical Trials Registry as ACTRN012605000042640. © 2009 American Society for Nutrition.

Estudio primario

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Eight-year outcomes of the Childhood Asthma Prevention Study.

Revista The Journal of allergy and clinical immunology
Año 2010
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Estudio primario

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Postnatal Fish Oil Supplementation in High-Risk Infants to Prevent Allergy: Randomized Controlled Trial.

Revista Pediatrics
Año 2012
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BACKGROUND AND OBJECTIVE: Relative deficiency of dietary omega 3 polyunsaturated fatty acids (n-3 PUFA) has been implicated in the rising allergy prevalence in Westernized countries. Fish oil supplementation may provide an intervention strategy for primary allergy prevention. The objective of this study was to assess the effect of fish oil n-3 PUFA supplementation from birth to 6 months of age on infant allergic disease. METHODS: In a double-blind randomized controlled trial, 420 infants at high atopic risk received a daily supplement of fish oil containing 280 mg docosahexaenoic acid and 110 mg eicosapentaenoic acid or a control (olive oil), from birth to age 6 months. PUFA levels were measured in 6-month-old infants' erythrocytes and plasma and their mothers' breast milk. Eczema, food allergy, asthma and sensitizaron were assessed in 323 infants for whom clinical follow-up was completed at 12 months of age. RESULTS: At 6 months of age, infant docosahexaenoic acid and eicosapentaenoic acid levels were significantly higher (both P&lt; .05) and erythrocyte arachidonic acid levels were lower (P= .003) in the fish oil group. Although n-3 PUFA levels at 6 months were associated with lower risk of eczema (P = .033) and recurrent wheeze (P = .027), the association with eczema was not significant after multiple comparisons and there was no effect of the intervention per se on the primary study outcomes. Specifically, between-group comparisons revealed no differences in the occurrence of allergic outcomes including sensitization, eczema, asthma, or food allergy. CONCLUSIONS: Postnatal fish oil supplementation improved infant n-3 status but did not prevent childhood allergic disease.

Estudio primario

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Impaired fetal growth and arterial wall thickening: a randomized trial of ω-3 supplementation.

Revista Pediatrics
Año 2012
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OBJECTIVES: Impaired fetal growth is an independent cardiovascular risk factor and is associated with arterial wall thickening in children. No preventive strategy has been identified. We sought to determine whether dietary ω-3 fatty acid supplementation during early childhood prevents the association between impaired fetal growth and carotid arterial wall thickening. METHODS: The Childhood Asthma Prevention Study was a randomized, controlled single-blind trial in 616 children born at term, recruited antenatally from maternity hospitals in Sydney. Participants were randomized to either a 500-mg-daily fish oil supplement and canola-based margarines and cooking oil (ω-3 group), or a 500-mg-daily sunflower oil supplement and ω-6 fatty acid-rich margarines and cooking oil (control group), from the start of bottle-feeding or 6 months of age until 5 years of age. Carotid intima-media thickness (IMT), a noninvasive measure of subclinical atherosclerosis, was the primary endpoint of a cardiovascular substudy (CardioCAPS) at age 8 years. We examined the association of fetal growth with carotid IMT in children with birth weight <90th percentile (ω-3 group [n = 187], control group [n = 176]). RESULTS: In the control group, fetal growth was inversely associated with carotid IMT, but this was prevented in the ω-3 group (difference between groups of 0.041 mm [95% confidence interval 0.006, 0.075] per kg birth weight, adjusted for gestational age and gender, P(heterogeneity) = .02). CONCLUSIONS: The inverse association of fetal growth with arterial wall thickness in childhood can be prevented by dietary ω-3 fatty acid supplementation over the first 5 years of life.

Estudio primario

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Outcomes of the childhood asthma prevention study at 11.5 years.

Revista The Journal of allergy and clinical immunology
Año 2013
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Estudio primario

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Omega-3 supplementation during the first 5 years of life and later academic performance: a randomised controlled trial.

Revista European journal of clinical nutrition
Año 2015
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<b>Background/objectives: </b>Consumption of oily fish more than once per week has been shown to improve cognitive outcomes in children. However, it is unknown whether similar benefits can be achieved by long-term omega-3 fatty acid supplementation. The objective was to investigate the effect of omega-3 fatty acid supplementation during the first 5 years of life on subsequent academic performance in children by conducting a secondary analysis of the CAPS (Childhood Asthma Prevention Study).<b>Subjects/methods: </b>A total of 616 infants with a family history of asthma were randomised to receive tuna fish oil (high in long-chain omega-3 fatty acids, active) or Sunola oil (low in omega-3 fatty acids, control) from the time breastfeeding ceased or at the age of 6 months until the age of 5 years. Academic performance was measured by a nationally standardised assessment of literacy and numeracy (National Assessment Program Literacy and Numeracy (NAPLAN)) in school years 3, 5, 7 and 9. Plasma omega-3 fatty acid levels were measured at regular intervals until 8 years of age. Between-group differences in test scores, adjusted for maternal age, birth weight and maternal education, were estimated using mixed-model regression.<b>RESULTS: </b>Among 239 children, there were no significant differences in NAPLAN scores between active and control groups. However, at 8 years, the proportion of omega-3 fatty acid in plasma was positively associated with the NAPLAN score (0.13 s.d. unit increase in score per 1% absolute increase in plasma omega-3 fatty acid (95% CI 0.03, 0.23)).<b>CONCLUSIONS: </b>Our findings do not support the practice of supplementing omega-3 fatty acids in the diet of young children to improve academic outcomes. Further exploration is needed to understand the association between plasma omega-3 fatty acid levels at 8 years and academic performance.

Estudio primario

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Cohort profile: The Childhood Asthma Prevention Study (CAPS).

Revista International journal of epidemiology
Año 2018
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Estudio primario

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Pertussis vaccination and allergic illness in Australian children.

Revista Applied Immunohistochemistry & Molecular Morphology
Año 2020
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