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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05449756

Enrollment

705

Registered

2022-07-08

Start date

2023-05-30

Completion date

2029-03-31

Last updated

2023-12-11

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

Conditions

Allergy, Infections

Brief summary

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

OTHERSelf-administered questionnaires

Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 10 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Parent-reported symptoms of allergies and infections	7.5 years	The occurrence of parent-reported - symptoms suggestive of allergies and infections
Parent-reported use of medications and/or a medical device	7.5 years	The occurrence of parent-reported - use of medications and/or a medical device to prevent or relieve symptoms suggestive of allergies and infections
Parent-reported - hospitalisations and visits to the emergency room	7.5 years	The occurrence of parent-reported - hospitalisations and visits to the emergency room for symptoms suggestive of allergies and infections

Countries

Netherlands

Contacts

Primary ContactDanone Nutricia Research Research

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026