Eczema, Egg Allergy, Food Allergy
Conditions
Keywords
peanut allergy, egg allergy, eczema, peanut, allergy, allergies, allergic reaction, anaphylaxis, infants, children
Brief summary
This study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).
Detailed description
Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are allergic to eggs; these children have a 20% chance of developing peanut allergy by the age of five. The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months, often at the time of their first exposure to peanut. Currently, there is no cure for peanut allergy. Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom. Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life, the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003. In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa, Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to be increasing. Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts. Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut. Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life. A physical exam, allergy testing, and other immune system tests requiring blood collection will occur at Years 1, 3, and 5 following study entry. During the study, parents will maintain regular contact with study dietitians.
Interventions
BIOLOGICALPeanut Consumption Group
Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
Sponsors
Immune Tolerance Network (ITN)
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 10 Months
Healthy volunteers
No
Inclusion criteria
* Able to consume solid food * Allergy to eggs and/or severe eczema * Informed consent obtained from parent or guardian.
Exclusion criteria
* Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded. * Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control * Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week * Investigator-suspected allergy to peanut protein * Investigator-suspected allergy to peanut protein in care provider or current household member. * Diagnosis of persistent asthma * ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value * BUN or creatinine greater than 1.25 times the upper limit of age-related normal value * Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise * Unwillingness or inability to comply with study requirements and procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum | 60 months | At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy. |
| Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined | 60 months | At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD at 60 Months | 60 months | At 60 months of age, participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD). This measure was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child's eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema. |
| Number of Participants With Asthma at 60 Months | 60 months | At 60 months of age, participants were assessed for asthma. Participants were considered to have asthma if they had a history of cough, wheeze, or shortness of breath that (1) was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, (2) required one visit to a physician in the previous 24 months, or (3) occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months. |
| Number of Participants With Rhinitis at 60 Months | 60 months | At 60 months of age, participants were assessed for rhinitis. Two types of rhinitis were assessed, perennial rhinoconjunctivitis and seasonal rhinoconjunctivitis. Participants were considered to have either type of rhinitis if they showed a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced either when exposed to the relevant allergen (perennial) or during the relevant season (seasonal). |
| Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | 60 months | At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific sensitivity if a skin prick containing the allergen produced a wheal size measuring greater than or equal to 3 mm. |
| Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | 60 months | At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific food sensitivity if a blood draw showed specific IgE levels greater than or equal to 0.35 kU/L for selected ingested allergens. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants between 4 and 11 months of age with pre-existing allergy to egg and/or severe eczema were recruited in the United Kingdom between December 2006 and May 2009.
Pre-assignment details
Participants were stratified into cohorts based on a skin prick test for peanut allergen. Participants were either negative (no measureable wheal after test) or positive (a wheal measuring between 1 and 4 mm in diameter). Participants were then randomized into treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Negative Stratum - Peanut Avoidance Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. | 270 |
| Negative Stratum - Peanut Consumption Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. | 272 |
| Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation. | 51 |
| Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. | 47 |
| Total | 640 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Other | 1 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Negative Stratum - Peanut Consumption Group | Positive Stratum - Peanut Avoidance Group | Positive Stratum - Peanut Consumption Group | Total | Negative Stratum - Peanut Avoidance Group |
|---|---|---|---|---|---|
| Age at Onset of Eczema | 2.3 Months STANDARD_DEVIATION 1.6 | 2.1 Months STANDARD_DEVIATION 1.6 | 2.4 Months STANDARD_DEVIATION 1.5 | 2.3 Months STANDARD_DEVIATION 1.6 | 2.2 Months STANDARD_DEVIATION 1.7 |
| Age, Continuous | 7.7 Months STANDARD_DEVIATION 1.8 | 8.4 Months STANDARD_DEVIATION 1.7 | 7.9 Months STANDARD_DEVIATION 1.6 | 7.8 Months STANDARD_DEVIATION 1.7 | 7.7 Months STANDARD_DEVIATION 1.7 |
| Peanut-specific IgE | 0.0 kUA/L | 0.4 kUA/L | 1.3 kUA/L | 0.0 kUA/L | 0.0 kUA/L |
| Region of Enrollment United Kingdom | 272 Participants | 51 Participants | 47 Participants | 640 Participants | 270 Participants |
| SCORAD | 33.3 units on a scale STANDARD_DEVIATION 18.4 | 33.7 units on a scale STANDARD_DEVIATION 16.2 | 37.8 units on a scale STANDARD_DEVIATION 18.6 | 34.4 units on a scale STANDARD_DEVIATION 18.9 | 35.0 units on a scale STANDARD_DEVIATION 19.9 |
| Severe Eczema | 246 Participants | 48 Participants | 41 Participants | 571 Participants | 236 Participants |
| Sex: Female, Male Female | 124 Participants | 17 Participants | 19 Participants | 256 Participants | 96 Participants |
| Sex: Female, Male Male | 148 Participants | 34 Participants | 28 Participants | 384 Participants | 174 Participants |
| Total IgE | 76.4 kUA/L STANDARD_DEVIATION 181.4 | 125.7 kUA/L STANDARD_DEVIATION 174.8 | 306.4 kUA/L STANDARD_DEVIATION 666.5 | 104.8 kUA/L STANDARD_DEVIATION 307.9 | 95.1 kUA/L STANDARD_DEVIATION 321.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 268 / 270 | 271 / 272 | 51 / 51 | 47 / 47 |
| serious Total, serious adverse events | 55 / 270 | 47 / 272 | 15 / 51 | 14 / 47 |
Outcome results
Primary
Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined
At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.
Time frame: 60 months
Population: Intent-to-treat - all randomly assigned participants who were evaluable for peanut allergy at age 60 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined | 54 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined | 10 Participants |
p-value: <0.0001Chi-squared
Primary
Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum
At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.
Time frame: 60 months
Population: Intent-to-treat - all randomly assigned participants who were evaluable for peanut allergy at age 60 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum | 36 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum | 5 Participants |
| Positive Stratum - Peanut Avoidance Group | Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum | 18 Participants |
| Positive Stratum - Peanut Consumption Group | Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum | 5 Participants |
p-value: <0.0001Chi-squared
p-value: 0.004Chi-squared
Secondary
Number of Participants With Asthma at 60 Months
At 60 months of age, participants were assessed for asthma. Participants were considered to have asthma if they had a history of cough, wheeze, or shortness of breath that (1) was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, (2) required one visit to a physician in the previous 24 months, or (3) occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months.
Time frame: 60 months
Population: Intent-to-treat with asthma data available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Asthma at 60 Months | 50 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Asthma at 60 Months | 54 Participants |
p-value: 0.642Chi-squared
Secondary
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L
At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific food sensitivity if a blood draw showed specific IgE levels greater than or equal to 0.35 kU/L for selected ingested allergens.
Time frame: 60 months
Population: Intent-to-treat with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Walnut IgE | 52 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Brazil nut IgE | 45 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Milk IgE | 99 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Hazel nut IgE | 101 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Egg IgE | 120 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Cashew IgE | 61 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Sesame IgE | 89 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Almond IgE | 62 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Peanut IgE | 93 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Almond IgE | 71 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Walnut IgE | 70 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Peanut IgE | 88 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Egg IgE | 114 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Milk IgE | 105 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Sesame IgE | 104 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Brazil nut IgE | 55 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Hazel nut IgE | 116 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L | Cashew IgE | 73 Participants |
Comparison: Comparison for Peanut IgEp-value: 0.859Chi-squared
Comparison: Comparison for Egg IgEp-value: 0.885Chi-squared
Comparison: Comparison for Milk IgEp-value: 0.403Chi-squared
Comparison: Comparison for Sesame IgEp-value: 0.106Chi-squared
Comparison: Comparison for Brazil Nut IgEp-value: 0.202Chi-squared
Comparison: Comparison for Hazel Nut IgEp-value: 0.108Chi-squared
Comparison: Comparison for Cashew IgEp-value: 0.157Chi-squared
Comparison: Comparison for Walnut IgEp-value: 0.04Chi-squared
Comparison: Comparison for Almond IgEp-value: 0.262Chi-squared
Secondary
Number of Participants With Rhinitis at 60 Months
At 60 months of age, participants were assessed for rhinitis. Two types of rhinitis were assessed, perennial rhinoconjunctivitis and seasonal rhinoconjunctivitis. Participants were considered to have either type of rhinitis if they showed a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced either when exposed to the relevant allergen (perennial) or during the relevant season (seasonal).
Time frame: 60 months
Population: Intent-to-treat with rhinitis data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Rhinitis at 60 Months | Perennial Rhinoconjunctivitis | 134 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Rhinitis at 60 Months | Seasonal Rhinoconjunctivitis | 106 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Rhinitis at 60 Months | Seasonal Rhinoconjunctivitis | 115 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Rhinitis at 60 Months | Perennial Rhinoconjunctivitis | 132 Participants |
Comparison: Comparison for Seasonal Rhinoconjunctivitisp-value: 0.417Chi-squared
Comparison: Comparison for Perennial Rhinoconjunctivitisp-value: 0.926Chi-squared
Secondary
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm
At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific sensitivity if a skin prick containing the allergen produced a wheal size measuring greater than or equal to 3 mm.
Time frame: 60 months
Population: Intent-to-treat with data available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Peanut Wheal | 71 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Brazil nut Wheal | 29 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Egg Wheal | 96 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Hazel nut Wheal | 34 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Sesame Wheal | 22 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Cashew Wheal | 42 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Almond Wheal | 42 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Walnut Wheal | 27 Participants |
| Negative Stratum - Peanut Avoidance Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Milk Wheal | 28 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Walnut Wheal | 34 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Milk Wheal | 25 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Sesame Wheal | 22 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Brazil nut Wheal | 26 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Almond Wheal | 50 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Peanut Wheal | 30 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Hazel nut Wheal | 41 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Cashew Wheal | 59 Participants |
| Negative Stratum - Peanut Consumption Group | Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm | Egg Wheal | 102 Participants |
Comparison: Comparison for Peanut Whealp-value: <0.001Chi-squared
Comparison: Comparison for Egg Whealp-value: 0.361Chi-squared
Comparison: Comparison for Milk Whealp-value: 0.76Chi-squared
Comparison: Comparison for Sesame Whealp-value: 0.834Chi-squared
Comparison: Comparison for Brazil Nut Whealp-value: 0.882Chi-squared
Comparison: Comparison for Hazel Nut Whealp-value: 0.226Chi-squared
Comparison: Comparison for Cashew Whealp-value: 0.024Chi-squared
Comparison: Comparison for Walnut Whealp-value: 0.204Chi-squared
Comparison: Comparison for Almond Whealp-value: 0.194Chi-squared
Secondary
SCORAD at 60 Months
At 60 months of age, participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD). This measure was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child's eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
Time frame: 60 months
Population: Intent-to-treat with SCORAD data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Negative Stratum - Peanut Avoidance Group | SCORAD at 60 Months | 7.6 units on a scale | Standard Deviation 11.6 |
| Negative Stratum - Peanut Consumption Group | SCORAD at 60 Months | 6.6 units on a scale | Standard Deviation 10.7 |
p-value: 0.369Wilcoxon (Mann-Whitney)