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.
1 other identifier
observational
705
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
December 11, 2023
December 1, 2023
5.8 years
July 4, 2022
December 4, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Parent-reported symptoms of allergies and infections
The occurrence of parent-reported - symptoms suggestive of allergies and infections
7.5 years
Parent-reported use of medications and/or a medical device
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
The occurrence of parent-reported - hospitalisations and visits to the emergency room for symptoms suggestive of allergies and infections
7.5 years
Study Arms (1)
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
Interventions
Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer)
Eligibility Criteria
TEMPO study subjects who completed the final (12 months) visit in the TEMPO study and consented to be approached for follow-up
You may qualify if:
- 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.
You may not qualify if:
- Parents who do not have a smartphone, tablet or personal computer with internet access.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PreCare Trial & Recruitment
Beek, 6191 JW, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2022
First Posted
July 8, 2022
Study Start
May 30, 2023
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
March 31, 2029
Last Updated
December 11, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share