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

Sponsor

Nutricia Research (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05449756

Collaborator

(none)

705

Enrollment

78.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergy Infections	Other: Self-administered questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

705 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2029

Anticipated Study Completion Date :

Mar 31, 2029

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

The occurrence of parent-reported - symptoms suggestive of allergies and infections [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]
The occurrence of parent-reported - hospitalisations and visits to the emergency room for symptoms suggestive of allergies and infections [7.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nutricia Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nutricia Research

ClinicalTrials.gov Identifier:

NCT05449756

Other Study ID Numbers:

EBB18TA23570

First Posted:

Jul 8, 2022

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Hypersensitivity

Study Results

No Results Posted as of Jul 13, 2022