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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

455 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-21

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Partially hydrolyzed protein Infant formula

Originating from A.R.T. cohort.

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

Intervention Type OTHER

The current study is a post-intervention study; interventions were given in the original A.R.T. study

Standard infant formula

Originating from A.R.T. cohort.

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

Intervention Type OTHER

The current study is a post-intervention study; interventions were given in the original A.R.T. study

Exclusively breastfed infants

Originating from A.R.T. cohort.

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

Intervention Type OTHER

The current study is a post-intervention study; interventions were given in the original A.R.T. study

Interventions

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

The current study is a post-intervention study; interventions were given in the original A.R.T. study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

63 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No