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

NCT ID: NCT05449756

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

705 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-30

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergy Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children who participated in randomised clinical trail, called TEMPO, in their first year of life

Children who participated in randomised clinical trail, called TEMPO, in their first year of life

Self-administered questionnaires

Intervention Type OTHER

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

Interventions

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Self-administered questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutricia Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PreCare Trial & Recruitment

Beek, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Danone Nutricia Research Research

Role: CONTACT

Phone: +31 30 2095 000

Email: [email protected]

Facility Contacts

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Vivienne van de Walle, Dr

Role: primary

Other Identifiers

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EBB18TA23570

Identifier Type: -

Identifier Source: org_study_id