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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administered questionnaires | Other | Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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TEMPO study subjects who completed the final (12 months) visit in the TEMPO study and consented to be approached for follow-up
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danone Nutricia Research Research | Contact | +31 30 2095 000 | register.clinicalresearchnutricia@danone.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PreCare Trial & Recruitment | Recruiting | Beek | 6191 JW | Netherlands |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D007239 | Infections |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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