Trial · NCT07895095
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tolerance to peanut (4000 mg) | 1-1.5 years after enrollment | Proportion of children who tolerate a cumulative dose of 4000 mg of peanut protein at an oral food challenge |
| Secondary | Tolerance to peanut (1000 mg) | 1-1.5 years after enrollment | Proportion of children who tolerate a cumulative dose of 1000 mg of peanut protein at an oral food challenge |
| Secondary | Eliciting dose | At enrollment and 1-1.5 years after enrollment | Change in cumulative eliciting dose at an oral food challenge (mg peanut protein) |
| Secondary | Allergic reactions | 6 months, 1-1.5 years, and 2-2.5 years after enrollment | Proportion of children experiencing allergic reactions to peanut outside the oral food challenge, the number of reactions per child, and the severity of the reactions (World Allergy Organization grading system, grade 1-5; higher grades indicate more severe reactions) |
| Secondary | Use of adrenaline auto-injector | 6 months, 1-1.5 years, and 2-2.5 years after enrollment | Proportion of children for whom an adrenaline auto-injector was used due to allergic reactions to peanut outside the oral food challenge, and the number of uses per child |
| Secondary | Severity of allergic reactions at the oral food challenge according to the World Allergy Organization Grading System | 1-1.5 years after enrollment | Severity of allergic reactions to peanut at the oral food challenge, graded by the World Allergy Organization grading system (grade 1-5; higher grades indicate more severe reactions) |
| Secondary | Parental food allergy-related quality of life | At enrollment, 1-1.5 years, and 2-2.5 years after enrollment | Changes in quality of life scores measured by the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB). Total scores range from 0 to 102, with higher scores indicating worse food allergy-related quality of life |
| Secondary | Parental food allergy-related anxiety | At enrollment, 1-1.5 years, and 2-2.5 years after enrollment | Changes in anxiety scores measured by the Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT). Total scores range from 0 to 196. Subscale scores are also reported: Cognitive subscale (range 9 to 63), Behavioral subscale (range 9 to 63), Anxiety impact (range 8 to 56), and Child coping (range 2 to 14). For all scores, higher values indicate greater food allergy-related burden. |
| Secondary | Changes in specific immunoglobulin E (IgE) | At enrollment, 1-1.5 years, and 2-2.5 years after enrollment | Changes in peanut-specific IgE (kU/L) |
| Other | Characterization of allergic reactions during oral immunotherapy | During oral immunotherapy up-dosing and maintenance phase | The anticipated cause, the treatment received, the timing, and whether the reaction followed a dose increase |
| Other | Duration of oral immunotherapy up-dosing phase | End of up-dosing phase (approximately 6 months after enrollment) | The duration of the up-dosing phase, and the reasons for deviations from the planned schedule |
| Other | Study dropout | 6 months, 1-1.5 years, and 2-2.5 years after enrollment | Proportion of children who dropped out, the phase of the study at dropout, and the reasons for dropout |
| Other | Missed oral immunotherapy doses | 6 months and 1-1.5 years after enrollment | Proportion of missed oral immunotherapy doses, and the reasons for missed doses |
| Other | Long-term tolerance of peanut | 2-2.5 years after enrollment | Proportion of participants who still tolerate peanut among those whose peanut allergy resolved 1-1.5 years after enrollment |
| Other | Frequency of peanut intake | 2-2.5 years after enrollment | Frequency of peanut intake (daily, weekly, monthly or less than monthly) among participants whose peanut allergy resolved 1-1.5 years after enrollment |
| Other | Is oral immunotherapy worth it | 1-1.5 years and 2-2.5 years after enrollment | Proportion of families who considered oral immunotherapy worthwhile, and their reported key benefits and burdens |
| Other | Decisional conflict | Right after the shared decision-making process using the decision aid | Scores on the Decisional Conflict Scale. Total scores range from 0 to 100, with higher scores indicating greater decisional conflict |
| Other | Eosinophilic esophagitis | 1-1.5 years after enrollment | Proportion of children with symptoms suggestive of eosinophilic esophagitis, and the proportion with a biopsy-confirmed diagnosis |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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