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

NCT05418491 | Completed

• 1 other identifier: A.R.T. Follow-Up
• Study Type: observational
• Target: 455
• Locations: 3 countries
• Sites: 3

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.

Conditions

Allergy

Keywords

post-intervention, allergic manifestations

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Partially hydrolyzed protein Infant formula

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

Standard infant formula

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

Exclusively breastfed infants

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

Interventions

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

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

Exclusively breastfed infants; Partially hydrolyzed protein Infant formula; Standard infant formula

Eligibility Criteria

• Age: 5 Years - 63 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The target population of the present study are all the A.R.T. subjects who consisted the Intention-to-Treat (ITT) population (N=551).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FrieslandCampina: lead

Study Sites (3)

Medical University of Varna

Varna, 9002, Bulgaria

Location

Asthma and Allergy Centre LTD

Limassol, 24 Nafpliou Street, 3025, Cyprus

Location

Harokopio University

Athens, Thiseos 70, Kallithea 176 71, Greece

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Yannis Manios, Dr.

  Harokopio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 14, 2022
• Study Start: July 21, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1); GR (1); CY (1)