Prevention of Allergic Diseases in Infants

Not Applicable

Active, not recruiting

• Conditions: Atopic Diseases
• Interventions: Other: Hydrolyzed Formula; Other: Control formula

• Registration Number: NCT03489733
• Lead Sponsor: HiPP GmbH & Co. Vertrieb KG

Brief Summary

A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Study Start: 2018-07-09
• Primary Completion: 2021-03-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1170

Inclusion Criteria

• Healthy term-born male and female infants (gestational Age ≥37+0, singleton birth)

• Birth weight ≥ 2500 g and ≤ 4500 g

• Age at enrollment: ≤ 56 days of life

• At risk of developing atopic diseases

• Free of atopy symptoms at Screening and at any time before randomization

• Feeding regimen at any time before Screening (V1) and Baseline (V2, infants who will receive Interventional Product (IP)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. Neocate Infant), maltodextrin or glucose solution/gel; breastfeeding allowed

• Subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. Subject's parents/caregivers will decide which feeding regimen will be used (IP or breast milk):

  • IP regimen (intervention or control group): only IP and breast milk until at least 120 days of life
  • breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life.
  • No other infant formulas or solid foods are allowed.

• Written informed consent.

Exclusion Criteria

• Multiple births
• Premature delivery (gestational age ≤ 36+6)
• Neonatal illnesses that might have an impact on allergy development (based on Investigator's decision)
• Significant congenital abnormalities
• Participation in another clinical study with an IP or study method that would influence the outcome of this study
• Reason to presume that the subject's parents/caregivers are unable to meet study plan requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Hydrolyzed Formula	Infant Formula with hydrolyzed protein and breast milk until at least 120 days of life
Control Group	Control formula	Infant Formula with intact protein and breast milk until at least 120 days of life

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of atopic dermatitis	1 year	Presence of atopic dermatitis on physical examination

Trial Locations

Locations (14)

Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD; 🇧🇬 Sofia, Bulgaria

Nemocnice Strakonice, a.s.; 🇨🇿 Strakonice, Czechia

Suomen Terveystalo Oy; 🇫🇮 Tampere, Finland

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital; 🇩🇪 Bochum, Germany

Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM); 🇩🇪 Frankfurt, Germany

Klinik für Kinder und Jugendmedizin; 🇩🇪 Hamm, Germany

Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel; 🇩🇪 Wesel, Germany

Instytut Mikroekologii; 🇵🇱 Poznań, Poland

Hospital braga; 🇵🇹 Braga, Portugal

Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"; 🇷🇸 Belgrade, Serbia

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago De Compostela, Spain

Unità Allergologia-Unità Allergologia-; 🇮🇹 Roma, Italy