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

FrieslandCampina455 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

455

Conditions

Allergy

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 63 Months

Medical Language ↔ Plain English

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

Locations (3)

Medical University of Varna

Varna, Bulgaria

Asthma and Allergy Centre LTD

Limassol, Cyprus

Harokopio University

Athens, Greece

Outcomes

Primary Outcomes

Incidence of allergic Manifestations

Incidence of allergic manifestations (AM) based on parental reporting using Childhood Allergy questionnaire comparing partially hydrolyzed protein formula, standard formula and exclusive breastfeeding.

Time frame: At 5 years of age