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Notes: With a new allergen-coated lancet (Phazet), skin prick tests can be made directly on the skin without separate use of liquid extract (the Phazet dry method), and reactions are recorded as for the ordinary method with liquid allergen extract (Pharmalgen) (the Pharmalgen wet method). 100 children were tested in parallel with the two methods. As a double control each Phazet was used twice (Phazet 1 and 2) in each child, who was tested with nine standard allergens. Good agreement was found between the results obtained with the two methods and also between Phazet 1 and Phazet 2. No general reactions were shown in relation to the numerous skin prick tests with allergen extract of a strength up to 100,000 BU/ml. 66% of the children preferred the Phazet while 22% had no preference.

Notes: Screening of total IgE in 2814 cord blood samples was analysed by Phadebas IgE PRIST in 2 1-year birth cohorts (1983-1984 and 1985–1986) in Denmark (n=1189+ 1625). 48.6% of the sera contained less IgE than the detection limit 0.1 kU/1. Cord blood IgE values 〉 0.5 kU/1 were regarded as elevated. 13.2% of the sera contained at least 0.5 kU/1 of IgE, with a significant preponderance in boys. Geometric mean cord blood IgE was 0.13 kU/1 and 0.12 kU/1, respectively. Geometric mean cord blood IgE was significantly higher in boys. A significant seasonal variation with lowest IgE values in the autumn was found. No correlation between cord blood IgE and birth weight or gestational age was demonstrated. Only few newborns had cord blood igA values 〉 0.014 g/l, calculated as geometric mean cord blood IgA + 2 SD among children with no detectable cord blood IgE, indicating infrequent contamination with maternal blood.Clinical aspectsUsing a simple cord blood sampling method and a sensitive IgE analysis., Phadebas IgE Prist, reproducible results of cord blood IgE in 2 unselected series of newborns were obtained. Cord blood IgA determination is recommended in all infants with cord blood IgE ≥ 1.0 kU/1 in order to exclude contamination with maternal blood.

Notes: Screening of total IgE in 2814 cord blood samples was analysed by Phadebas IgE PRIST in 2 1-year birth cohorts (1983–1984 and 1985–1986) in Denmark (n= 1189 + 1625). For follow-up we chose all infants with cord blood IgE≥0.5 kU/1 and a randomly chosen group of the same size with cord blood IgE 〈 0.5 kU/1. A total group of 762 infants were clinically evaluated at 18 months of age, and in 688 of these we evaluated total and specific IgE. A diagnosis of definite atopy, probable atopy or no atopy was established. In the present study we defined allergic disease as atopic disease combined with elevated total IgE. We found a statistically significant correlation between cord blood IgE and IgE at 18 months of age. Significantly more infants with elevated cord blood IgE had developed allergic disease at 18 months. A cut-off value of 0.3 kU/1 for cord blood IgE was superior to the originally suggested 0.5 kU/1.Significantly more infants with elevated cord blood IgE had developed specific IgE antibodies at 18 months. The most frequent specific IgE antibody was towards cow's milk. Specific IgE antibodies were very rarely found when total IgE was not elevated. A total IgE at the age of 18 months 〉 26 kU/1 could be regarded as elevated. With regard to allergic disease the positive predictive values of cord blood lgE≥0.3 kU/1 in the 2 series were 21 % and the corresponding sensitivities 67% and 46%, respectively. The risk of developing allergic disease was elevated with a factor 3 to 4 when cord blood IgE ≥ 0.3 kU/1. In a high-risk group based on atopic predisposition and elevated eord blood IgE ≥0.5 kU/1 the relative risk of allergic disease was 5, the predictive value of positive test 38%, the sensitivity 24% and the specificity 96%. Clinical aspects Cord blood IgE was a good predictor of allergic disease at the age of 18 months. A cord blood cut-off IgE value of 0.3 kU/l was superior to other cord blood IgE values with the Phadebas IgE PRIST method.

Notes: In a prospective study of a 1-year birth cohort of 158 high-risk infants the effect of feeding breastmilk, a casein hydrolysate (Nutramigen®) or a new ultrafiltrated whey hydrolysate (Profylac®) on the development of cow milk protein allergy/intolerance (CMPA/CMPI) was assessed and compared. All the infants had biparental or severe single atopic predisposition, the latter combined with cord blood IgE ≥ 0. 5 kU/L. At birth all infants were randomized to Nutramigen or Profylac, which was used when breastfeeding was insufficient or not possible during the first 6 months of life. During the same period this regimen was combined with avoidance of solid foods and cow milk protein. All mothers had unrestricted diets and were encouraged to do breastfeeding only. Moreover, avoidance of daily exposure to tobacco smoking, furred pets and dust-collecting materials in the the bedroom was advised. The infants were followed prospectively from birth to 18 months of age. All possible atopic symptoms were registered and controlled elimination/challenge studies were performed when symptoms suggested CMPA/CMPI. A total of 154 (97%) were followed up and 141 followed the diet strictly. Eighty-eight (62%) of the infants were breastfed for at least 6 months, 20 (14%) were breastfed exclusively, 59 and 62 had varying amounts of Nutramigen or Profylac respectively. CMPA/CMPI was diagnosed in 1/20, 1/59 and 3/62 in the breastfed, the Nutramigen and Profylac groups respectively, but 1 of the latter also had Nutramigen. None of the infants showed reactions against Nutramigen or Profylac. In 4 infants symptoms were provoked by breastmilk when the mother ingested cow milk and in 1 only by cow milk. The incidence of CMPA/CMPI among the infants who followed the dietary prevention programme was 3. 6% (5/141) which was a significant reduction compared to 20% (15/75) in an identically defined high-risk group without dietary preventive measures. None of the infants in the prevention group developed CMPA/CMPI after the age of 6 months. We conclude that feeding breastmilk, an extensively hydrolysed casein formula (Nutramigen) or an ultrafiltrated whey hydrolysate (Profylac) combined with avoidance of solid foods during the first 6 months of life in high-risk infants significantly reduced the cumulative incidence of CMPA/CMPI during the first 18 months of life. No difference was noted whether the infants were fed breastmilk, Nutramigen or Profylac and a diet period of 6 months seems sufficient. Both formulae were well tolerated and accepted by the infants.

Notes: Screening of total IgE in 1189 cord blood samples was conducted by Phadebas IgE PRIST in a one-year birth cohort 1983-1984 in Viborg. Denmark. 113 children with cord blood IgE levels ≥ 0.5 kU/l and 138 children chosen at random among those with cord blood IgE levels 〈 0. 5 kU/l were seen at a follow-up at 5 years of age. Based upon history and physical examination a diagnosis of definite atopy or no atopy was established. Allergy (IgE mediated) was defined as atopic disease combined with increased total IgE levels at 5 years of age. The cumulative prevalence of atopic disease was not influenced by cord blood IgE levels or atopic predisposition. Cord blood IgE levels had a low sensitivity as a predictor of atopic disease. A statistically significant correlation between serum levels of IgE at birth and at 5 years was however found (p 〈 0.001), and a significantly greater number of children with elevated cord blood IgE levels developed allergic disease before 5 years of age (p 〈 0.01). A cut-off limit of 0. 3 kU/l was superior to the originally suggested limit of 0. 5 kU/l. A total IgE level 〉 63 kU/l (geometric mean + 1 SD) at the age of 5 years can be regarded as being an elevated level. A cord blood IgE level ≥ 0.3 kU/l in combination with atopic predisposition was predictive of allergic disease, especially allergic bronchial asthma. With regard to allergic disease, the positive predictive value was 26%, the sensitivity 33% and the rate ratio for development of allergic disease 4. In the case of the most serious atopic disease, allergic bronchial asthma, the positive predictive value was 20%, the sensitivity 87% and the rate ratio 68.

Notes: The purpose of this study was to determine whether a new ultrafiltrated whey hydrolysate infant formula, Profylac®, could be administered safely to children with cow milk protein allergy/intolerance. Profylac has a stated molecular weight of 〈 8 kD and at least 30, 000 times reduced antigenicity which is controlled by a combination of ELISA-techniques and immunochemical methods. The study comprised 66 children with cow milk protein allergy/intolerance diagnosed by controlled elimination/ challenge procedures. The children were aged 1 month-14. 5 years, median 1% years and 15 were below 1 year. Thirty-five of these children had proven IgE-mediated reactions (cow milk protein allergy). Sixty-one of the children had at least two different symptoms and 31 had concomitant allergies to other foods and/or inhalants. All 66 children underwent and tolerated open, controlled challenges with Profylac. A total of 64 children continued having Profylac daily for at least 3 months and 58 for at least 6 months after challenge. Nine of the children older than 1 year did not like the taste and only had Profylac in minor amounts. No side effects were registered. Fifteen of the infants were below 1 year of age, and this group was compared with an age matched group of 16 infants challenged with and fed an extensively hydrolysed casein hydrolysate, Nutramigen®. All the infants in these two groups accepted and tolerated Profylac and Nutramigen, respectively, and no side effects were registered. Among the 35 patients with IgE-mediated reactions 6% (2/35) had positive skin prick tests and 11% (3/28) had specific IgE class 2 against Profylac, 2 of the latter before intake of Profylac. None of the patients with non-IgE-mediated reactions had a positive skin prick test or specific IgE against Profylac. The study provides 95% confidence that this product is tolerated by at least 95% of children with cow milk protein allergy/intolerance and by 90% with IgE-mediated reactions. We conclude, that this ultrafiltrated whey hydrolysate is generally safe to feed to children with verified adverse reactions to cow milk protein, including children with IgE-mediated reactions. The taste of the product was widely accepted, also by older children.

Notes: Human milk samples (n= 300) were collected during a 3-week period from 10 healthy mothers and from 10 atopic mothers, all with healthy, solely breast-fed infants. The milk samples were analysed by an enzyme-linked immunosorbent assay (ELISA) for the content of bovine β-lactoglobulin (BLG). In a cross-over design the atopic and non-atopic mothers alternated their intake of milk between homogenized and unhomogenized milk each week. On day 7, in each week, consecutive milk samples were taken before and 4, 8, 12 and 24 hr after a single ingestion of 500 ml of homogenized or unhomogenized milk. Detectable amounts of BLG (0·9–150 μg/1, median value 4·2 μg/1) were measured in 19/20 of the mothers (95%), in 9 of 10 atopic mothers and in all 10 of 10 non-atopic mothers. No correlation was found between the type of milk preparation (homogenized or unhomogenized) and the presence of BLG or the level of BLG in human milk. A great intra-individual and inter-individual variation of BLG level was found, and no relationship was observed between BLG levels and atopic status of the mothers. The interval between ingestion of 500 ml of milk and the maximal concentration of BLG on milk-free diet varied between 4 and 24 hr, median value 8 hr. The presence of BLG in human milk is a common finding in both atopic and non-atopic mothers.

Notes: In a multicenter study conducted at four Danish hospital pediatric departments, the parents of 472 consecutive children were informed of this project to determine the incidence of intolerance of food additives among children referred to an allergy clinic with symptoms of asthma, atopic dermatitis, rhinitis, or urticaria. After a 2-week period on an additive-free diet, the children were challenged with the eliminated additives. The food additives investigated were coloring agents, preservatives, citric acid, and flavoring agents. Carbonated “lemonade” containing the dissolved additives was used for the open challenge. Two doses were used: a low dose and a 10-fold higher dose. Gelatin capsules were used for a double-blind challenge. The children were 4–15 years old, and they were attending an outpatient pediatric clinic for the first time. Of the 379 patients who entered the study, 44 were excluded and 335 were subjected to open challenge. A total of 23 children developed positive reactions after the open challenge. Sixteen of these patients accepted the double-blind challenge, and six showed a positive reaction to preservatives (atopic dermatitis, asthma, rhinitis), coloring agents (atopic dermatitis, asthma, urticaria, gastrointestinal symptoms), and citric acid (atopic dermatitis, gastrointestinal symptoms). The incidence of intolerance of food additives was 2% (6/335), as based on the double-blind challenge, and 7% (23/335), as based on the open challenge with lemonade. Children with atopic skin symptoms had a statistically increased risk of a positive reaction. This may have consequences for the future clinical investigation of children with atopic cutaneous symptoms.

Notes: Screening of total IgE in 2814 cord blood samples was analysed by Phadebas IgE PRIST in 2 1-year birth cohorts (1983-1984 and 1985–1986) in Denmark (n = 1189 + 1625). For follow-up we chose all infants with cord blood IgE ≥ 0.5 kU/1 and a randomly chosen group of the same size with cord blood IgE 〈 0.5 kU/1. A total of 762 infants were clinically evaluated at 18 months of age. A diagnosis of definite atopy, probable atopy or no atopy, including both IgE and non-IgE mediated disease was established. Applying different cord blood IgE cut-off values (0.3, 0.5, 0.8, 1.1) we did not find an excess of atopic infants among those with elevated cord blood IgE irrespective of the chosen cut-off value. Atopic predisposition or family history of atopic disease was defined as at least one parent or older siblitig with atopic disease. Significantly more infants with a family history developed atopy at 18 months. In the 2 series the positive predictive values of cord blood IgE≥0.5 were 43% and 46% and the sensitivities were 17% and 15%. The predictive values of having a family history were 48% and 44% and the sensitivities were 55% and 58%. Clinical aspects Cord blood IgE analysed by Phadebas IgE PRIST was a poor predictor of infants developing atopic disease before the age of 18 months.