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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449756
• Other study ID #: EBB18TA23570
• Status: Recruiting
• Start date: May 30, 2023
• Est. completion date: March 31, 2029

Study information

• Verified date: December 2023
• Source: Nutricia Research
• Contact: Danone Nutricia Research Research
• Phone: +31 30 2095 000
• Email: register.clinicalresearchnutricia[@]danone.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 705
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity
• Infections

Intervention

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

Locations

Country	Name	City	State
Netherlands	PreCare Trial & Recruitment	Beek

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent-reported symptoms of allergies and infections	The occurrence of parent-reported - symptoms suggestive of allergies and infections	7.5 years
Primary	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
Primary	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