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

ConditionsAllergyInfections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-10
SponsorNutricia Research

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Parents who do not have a smartphone, tablet or personal computer with internet access.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Self-administered questionnaires

    Other intervention

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

Treatment groups

705 Participants
are divided into 1 treatment group
Group A: Children who participated in randomised clinical trail, called TEMPO, in their first year of life1 intervention

Trial outcomes

Primary outcomes

1

Parent-reported symptoms of allergies and infections

The occurrence of parent-reported - symptoms suggestive of allergies and infections

Time frame
7.5 years
2

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

Time frame
7.5 years
3

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

Time frame
7.5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nutricia Research

Lead sponsor

Source ClinicalTrials.gov
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