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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05418491
Enrollment
455
Registered
2022-06-14
Start date
2022-07-21
Completion date
2024-07-31
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

post-intervention, allergic manifestations

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.

Interventions

OTHERNo 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

Sponsors

FrieslandCampina
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to 63 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of allergic ManifestationsAt 5 years of ageIncidence of allergic manifestations (AM) based on parental reporting using Childhood Allergy questionnaire comparing partially hydrolyzed protein formula, standard formula and exclusive breastfeeding.

Countries

Bulgaria, Cyprus, Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026