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NCT Number: NCT05449756

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

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.

Recruiting

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases Infections

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PreCare Trial & Recruitment

Beek, 6191 JW, Netherlands

Location status: Recruiting

Location contact

Vivienne van de Walle, Dr

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

self-administered questionnaires

Other

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

Primary outcomes

  1. Parent-reported symptoms of allergies and infections

    Time frame: 7.5 years

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

  2. Parent-reported use of medications and/or a medical device

    Time frame: 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

  3. Parent-reported - hospitalisations and visits to the emergency room

    Time frame: 7.5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Danone Nutricia Research Research

CONTACT

[email protected]

+31 30 2095 000

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jul 8, 2022
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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