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

FrieslandCampina

Status: Completed

Conditions: Allergy

Treatments: Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study

Study type: Observational

Funder types: Industry

Identifiers

NCT05418491

A.R.T. Follow-Up

Details and patient eligibility

About

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.

Full 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.

Enrollment: 455 patients

Sex: All

Ages: 5 years to 63 months old

Volunteers: No Healthy Volunteers

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

Trial design

455 participants in 3 patient groups

Partially hydrolyzed protein Infant formula

Description:

Originating from A.R.T. cohort.

Treatment:

Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study

Standard infant formula

Description:

Originating from A.R.T. cohort.

Treatment:

Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study

Exclusively breastfed infants

Description:

Originating from A.R.T. cohort.

Treatment:

Other: No intervention is used in the current study. Interventions were given in the original A.R.T. study