Actively Recruiting

Age: 3Years - 10Years
All Genders
Healthy Volunteers
ID05449756

A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood

Led by Nutricia Research · Updated on 2023-12-11

705

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research observes children who took part in the TEMPO clinical trial during their first year of life to understand if their early feeding patterns affect the development of allergies or infections in childhood. The study follows these children up to 7.5 years to gather information on allergic symptoms, infections, and related medical care. It is an observational study without additional treatments or interventions. Participants complete self-administered digital questionnaires every three months using a smartphone, tablet, or computer. These questionnaires collect data on allergies, infections, medication use, medical device use, hospitalizations, and emergency room visits. The study is entirely virtual and decentralized, allowing families to participate remotely. Throughout the study, parents provide information via regular online questionnaires, helping researchers track their child's health over time. The main measurements include parent-reported symptoms, medication or device use, and healthcare visits related to allergies and infections. The study runs until March 2029 and includes children aged 3 to 10 years who completed the original TEMPO study.

CONDITIONS

Brief Title

A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life

Who Can Participate

Age: 3Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children who completed the final (12 months) visit in the TEMPO study
  • Parents agree to share contact details with a third party for study purposes
  • Parents agree that data from the TEMPO study will be used in this follow-up study
  • Parents provide written informed consent for participation according to local law
Not Eligible

You will not qualify if you...

  • Parents do not have access to a smartphone, tablet, or personal computer with internet

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (virtual)

Long-term Monitoring

Duration - Up to 7.5 years

Participants complete self-administered digital questionnaires every three months to report on feeding patterns, allergic manifestations, allergies, infections, medication use, and healthcare visits.

Quarterly digital questionnaires accessed via smartphone, tablet, or computer

Trial Site Locations

Total: 1 location

1

PreCare Trial & Recruitment

Beek, Netherlands, 6191 JW

Actively Recruiting

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Research Team

D

Danone Nutricia Research Research

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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