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Digital guidance for introducing foods

Digital guidance for introducing foods to children with suspected food allergy (INTRODUCTORY trial) - Digital guidance for introducing foods

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57906
Enrollment
110
Registered
2025-04-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food allergy

Interventions

Parents &nbsp
are recommended to introduce peanut and/or tree nuts to thgeir children at home using our standardized schedules.&nbsp
Randomisation is performed to determine which guidance method applies, either the usual clinical practice using written information and schedules or the renewed practice using the&nbsp
digital guidance&nbsp
tool. Furthermore, all participants will be asked to fill out health-related quality of life questionnaires as well as questionnaires regarding user experience of the guidance method.

Sponsors

Martini Ziekenhuis
Lead Sponsor

Eligibility

Age
No minimum to 11 Years

Inclusion criteria

Inclusion criteria: Age 1 to 6 years; suspected to be allergic for almond, cashew nut, hazelnut, macadamia, peanut, pecan, pistachio or walnut (based on medical history); recommended to perform an introduction at home for almond, cashew nut, hazelnut, macadamia, peanut, pecan, pistachio or walnut.

Exclusion criteria

Exclusion criteria: Parents of infants who were referred for early introduction of peanut according to recently updated guidelines; previous introduction at home and/or oral food challenge is performed for the suspected food allergen; parent is unable to adequately report the occurrence of possible symptoms (e.g. mentally disabled or not native Dutch speaker).

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the number of completed introductions at home in both groups (current clinical practice compared to use of digital tool). 

Secondary

MeasureTime frame
The following secondary outcome measures will be analysed: decision of parents/patients to actually perform the introduction (i.e. accept or decline our advice), details of performed introductions at home (i.e. symptoms, medication use, contact with healthcare professionals), difference in health-related quality of life, and user experience of the digital tool.

Countries

Netherlands

Contacts

Public ContactA.W.A. Kamps

Martini Ziekenhuis

a.kamps@mzh.nl0505247088

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)