Clinical trial NCT03489733: Prevention of Allergic Diseases in Infants
Official title: The Effect of Low Protein, Extensively Hydrolyzed Infant Formula on Allergy Prevention in At-risk Infants up to 1 Year of Age: a Randomized, Double-blind, Controlled Intervention Study and the Long-term Effect on Allergy Prevention of Early Nutrition Given in the First 120 Days of Life in At-risk Infants Until the Child is 6 Years of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atopic Diseases
Lead sponsor: HiPP GmbH & Co. Vertrieb KG
Sponsor class: INDUSTRY
First posted: 2018-04-05
Enrollment: 1170
Sex: ALL
Maximum age (years): 56
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of atopic dermatitis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD
city: Strakonice
country: Czechia
facility: Nemocnice Strakonice, a.s.
city: Tampere
country: Finland
facility: Suomen Terveystalo Oy
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital
city: Frankfurt
country: Germany
facility: Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM)
city: Hamm
country: Germany
facility: Klinik für Kinder und Jugendmedizin
city: Wesel
country: Germany
facility: Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel
city: Roma
country: Italy
facility: Unità Allergologia-Unità Allergologia-
city: Poznań
country: Poland
facility: Instytut Mikroekologii
city: Braga
country: Portugal
facility: Hospital braga
city: Belgrade
country: Serbia
facility: Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
Study officials:
affiliation: Charite University, Berlin, Germany
name: Kirsten Beyer, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References: