Clinical trial NCT05418491: The Prolonged Effect of Consumption of a Partially Hydrolyzed Infant Formula During the First 6 Months of Life on the Development of Allergic Manifestations At 5 Years of Age
Official title: A Post-intervention Follow-up of the Allergy Reduction Trial, to Investigate the Prolonged Risk Reducing Effect of a Partially Hydrolysed Infant Formula During the First Six Months of Life on Allergic Manifestations Up to the Age of 5 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Keywords: post-intervention, allergic manifestations
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
First posted: 2022-06-14
Enrollment: 455
Sex: ALL
Minimum age (years): 5
Maximum age (years): 63
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of the present study are all the A.R.T. subjects who consisted the Intention-to-Treat (ITT) population (N=551).

Brief summary: The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen \[formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed\] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.

Detailed description: The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen \[formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed\] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.

Eligibility criteria: Inclusion Criteria:

* Children who were part of the Intention-to-Treat population of the A.R.T. study
* Children of the A.R.T. study ITT population within the age range of 5 years up to 5 years and 3 months
* Children of the A.R.T. study ITT population in whom at least one parent and/or legal guardian signed the written consent form

Exclusion Criteria:

* Children who did not participate in the A.R.T. study or who were not assigned to any of the 3 study arms
* Children of the A.R.T. study who are younger than 5 years of age or older than 5 years and 3 months of age
* Children of the A.R.T. study in whom parents and/or guardians do not agree to provide a written consent form

Primary outcomes:
measure: Incidence of allergic Manifestations
timeFrame: At 5 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Varna
country: Bulgaria
facility: Medical University of Varna
city: Limassol
country: Cyprus
facility: Asthma and Allergy Centre LTD
city: Athens
country: Greece
facility: Harokopio University
Study officials:
affiliation: Harokopio University
name: Yannis Manios, Dr.
role: PRINCIPAL_INVESTIGATOR
References: