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

Completed

• Conditions: Allergy

• Registration Number: NCT05418491
• Lead Sponsor: FrieslandCampina

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.

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-14
• Study Start: 2022-07-21
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 455

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of allergic Manifestations	At 5 years of age	Incidence of allergic manifestations (AM) based on parental reporting using Childhood Allergy questionnaire comparing partially hydrolyzed protein formula, standard formula and exclusive breastfeeding.

Trial Locations

Locations (3)

Medical University of Varna; 🇧🇬 Varna, Bulgaria

Asthma and Allergy Centre LTD; 🇨🇾 Limassol, Cyprus

Harokopio University; 🇬🇷 Athens, Greece