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

December 4, 2023 updated by: Nutricia Research

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

705

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Beek, Netherlands, 6191 JW
        • Recruiting
        • PreCare Trial & Recruitment
        • Contact:
          • Vivienne van de Walle, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

TEMPO study subjects who completed the final (12 months) visit in the TEMPO study and consented to be approached for follow-up

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children who participated in randomised clinical trail, called TEMPO, in their first year of life
Other: Self-administered questionnaires
Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBB18TA23570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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