Meglio 2013.
Methods | Randomized controlled trial, controlled open study | |
Participants | 20 children, aged 4 years to 14 years, with mild‐to‐severe IgE‐mediated HEA, according to Clark’s severity classification, were admitted. All fulfilled the inclusion criteria of being more than four yrs of age and having an IgE‐mediated HEA: positive hen's egg skin prick tests (SPTs) or hen's egg IgE > 0.35 kUA/L confirmed by means of double‐blind, placebo‐controlled food challenge (DBPCFC) or a convincing history | |
Interventions | The schedule consisted of administering increasing amounts of raw hen's egg starting from one drop (mixed egg white and yolk) diluted 1:100 with water, corresponding to 0.27 mg of hen's egg proteins. The hen's egg doses were doubled every 8 days until day 80. Subsequently, the hen's egg doses were doubled every 16 days to achieve a total daily intake of 25 mL, in 6 months.
The protocol was suspended when the child reached 25 mL/day or the maximum tolerated dose, that is to say the dose that did not induce any symptom and that was established after the third attempt to continue with the desensitization protocol (the parents tried to administer the same dose, which caused symptoms three times, so the previous tolerated dose was considered the maximum tolerated dose). Control: hen egg‐free diet. |
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Outcomes |
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Vested interest | This information was not available | |
Notes | Funding information was not available | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | By means of a computerized randomization schedule, the participants were randomly assigned to either intervention or control |
Allocation concealment (selection bias) | Low risk | Computerized randomization schedule |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded intervention |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available and therefore selective outcome reporting could not be assessed |