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

Study Overview
=================
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.

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

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 63 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Partially hydrolyzed protein Infant formula<br>Originating from A.R.T. cohort. | Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study<br>* The current study is a post-intervention study; interventions were given in the original A.R.T. study<br>|
| Standard infant formula<br>Originating from A.R.T. cohort. | Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study<br>* The current study is a post-intervention study; interventions were given in the original A.R.T. study<br>|
| Exclusively breastfed infants<br>Originating from A.R.T. cohort. | Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study<br>* The current study is a post-intervention study; interventions were given in the original A.R.T. study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 5 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-intervention, allergic manifestations