A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-administered questionnaires.
- Who it may be relevant to
- Registry conditions: Allergy, Infections. Basic parameters: 3 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood.
Overview
This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.
Interventions
- Other Self-administered questionnaires
Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer)
Primary outcome measures
- Parent-reported symptoms of allergies and infections [Time frame: 7.5 years]
- Parent-reported use of medications and/or a medical device [Time frame: 7.5 years]
- Parent-reported - hospitalisations and visits to the emergency room [Time frame: 7.5 years]
Eligibility criteria
Inclusion criteria
- Subjects are eligible to participate in the TEMPO Follow-Up study in case:
- they completed the final (12 months) visit in the TEMPO study.
- parents agree that their contact details will be shared with a third party for study purposes.
- parents agree that data collected in the TEMPO study will be used in the TEMPO Follow-Up study.
- parents provide written informed consent for participation in the TEMPO Follow-Up in accordance with local law.
Exclusion criteria
- Parents who do not have a smartphone, tablet or personal computer with internet access.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- PreCare Trial & Recruitment — Beek
Identifiers
NCT: NCT05449756 · EBB18TA23570