A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood.
Sponsor study identifier
observational
705
1 country
1
Study Start
May 30, 2023
Actual (reported)Primary Completion
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 4, 2022
Actual (reported)July 8, 2022
Actual (reported)May 30, 2023
Actual (reported)March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Children who participated in randomised clinical trail, called TEMPO, in their first year of life
Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
TEMPO study subjects who completed the final (12 months) visit in the TEMPO study and consented to be approached for follow-up
PreCare Trial & Recruitment
Beek, 6191 JW, Netherlands
First Submitted
July 4, 2022
First Posted
July 8, 2022
Study Start
May 30, 2023
Actual (reported)Primary Completion
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Birth Experience During COVID-19 Confinement
Contact the study team to confirm eligibility.
Study Completion
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 11, 2023
Record last verified: 2023-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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