Two-step Egg Introduction for Prevention of Egg Allergy in High-risk Infants With Eczema (PETIT): A Randomized, Double-blind, Placebo-Controlled Trial
PURPOSE OF THE STUDY.
The Prevention of Egg Allergy with Tiny Amount Intake is a double-blind, placebo-controlled trial that investigated the stepwise introduction of hen’s egg and the optimal eczema treatment for preventing an egg allergy at the age of 1 year.
Healthy Japanese infants with eczema and without previous ingestion of or reactions to hen’s egg (N = 147) were randomized (1:1, stratified by institution and sex) at the ages of 4–5 months to consume either egg or a placebo.
Infants in the egg group consumed 50 mg of heated egg powder per day from ages 6–9 months and consumed 250 mg per day from ages 9–12 months. Infants in the placebo group consumed squash powder with matched color and volume. At the age of 12 months, the proportion of infants with an egg allergy in each group was confirmed by open food challenges to 7 g of egg powder. Sensitization to egg was measured by egg-specific IgE level (sIgE), and eczema was assessed by Scoring Atopic Dermatitis (SCORAD) severity score.
The study was terminated when the interim analysis showed a protective effect of egg ingestion. Among infants completing the open egg challenge (N = 121), 5 (8%) had an egg allergy in the egg group versus 23 (38%) in the placebo group (risk ratio 0.221 [95% CI 0.090–0.543], P = .0001). In stratified analyses, egg ingestion was protective for egg-sensitized infants (sIgE ≥0.35 kUA/L, P = .001) but not for nonsensitized infants (sIgE <0.35 kUA/L, P = .31).
Daily consumption of a small amount of egg and aggressive eczema care starting at age 6 months prevents egg allergy in high-risk infants at age 12 months.
This stepwise egg introduction to infants with eczema appeared to be safe; no severe, immediate allergic reactions were reported at home, although anaphylaxis occurred during some monitored egg challenges. The significantly higher baseline egg sensitization rate and SCORAD in the placebo group were important limitations that may have affected the rates of egg allergy in the 2 groups and biased the results. The median baseline SCORAD was in the moderate range for the placebo group and in the mild range for the egg group; eczema was well controlled with minimal topical steroid use, suggesting that few infants had severe or difficult-to-control eczema.
- Copyright © 2017 by the American Academy of Pediatrics