Tempo Follow-Up

• Research type

  Research Study

• Full 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.

• IRAS ID

  329751

• Contact name

  Louise Michaelis

• Contact email

  louise.michaelis@nhs.net

• Sponsor organisation

  Danone Nutricia Research

• Clinicaltrials.gov Identifier

  NCT05449756, ClinicalTrials.gov

• Duration of Study in the UK

  5 years, 8 months, 30 days

• Research summary

  TEMPO Follow-Up is a virtual, decentralised follow-up study of a cohort of children who participated in the Nutricia Research TEMPO study (a double-blind randomised clinical trial investigating infant formula and human milk consumption in the first year of life). Data from the TEMPO study will be re-used and linked to newly collected data from the Follow up study.
  TEMPO Follow-Up is a longitudinal prospective observational cohort study. In the study only parent-reported information is collected. This is done through completion of three-monthly digital questionnaires that are accessed by the parents via a dedicated application that is installed on a self-owned mobile device (smartphone or tablet) or via web-based questionnaires using a personal computer. The majority of the children will be aged 4-6 years at enrolment. They will be followed up until they are 10 years of age.

  Objectives
  To describe the associations between feeding patterns in the first year of life and long-term pre-specified immune related outcomes in childhood.

  To describe the associations between subject characteristics during the first year of life such as mode of delivery, exposure to allergens, allergic sensitisation and microbiological composition and long-term pre-specified immune related outcomes in childhood.

  To describe associations between feeding patterns in the first year of life and parent-reported medication and/or medical device (inhaler) use, hospitalisation and visits to the emergency room to prevent, relieve or treat immune related outcomes in childhood.

  To describe the associations between diet in childhood and long-term immune related outcomes in childhood.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  23/WM/0279

• Date of REC Opinion

  21 Feb 2024

• REC opinion

  Further Information Favourable Opinion