Symptoms of respiratory tract infections, gastrointestinal tract infections and otitis media Symptoms of common cold, stomach flu and ear infections
Conditions
Interventions
In this study, we follow infants who receive formula based on either goat’s milk or cow’s milk.
Sponsors
Ausnutria B.V.
Eligibility
Inclusion criteria
Inclusion criteria: Singleton, term infants (37-42 weeks gestation).Aged = 3 months at study start.Written informed consent (ICF) from parent(s) and/or caregiver(s) aged =18 years. Exclusively fed with one formula type for a minimum of 7 consecutive days prior to start of study.Birth weight = 2.5 kg
Exclusion criteria
Exclusion criteria: Known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance.Consumed hydrolysed infant formula or other specialty formulas.Any health condition that would negatively impact the immune system.Participation in any clinical trial prior to or during the observational period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary objective is to examine how often infants experience infection symptoms in early life, such as:Cold symptomsStomach flu (gastroenteritis) symptomsEar infection symptomsThe presence of these infection symptoms is tracked by a short weekly questionnaire in which parents indicate which symptoms were present that week, how long they lasted, and how severe they were. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to explore associations between feeding type and parent-reported infections in early life, as well as regional influences and temporal patterns. These will be assessed through the following measures:Feeding type(s) consumed until the infant’s first birthday, specified as brand name and categorized as goat milk-based formula or cow’s milk-based formula.Introduction of weaning foods, assessed weekly until first introduction has occurred.Parental concerns about the infant’s health, reported weekly until the first birthday.Parental response to infections, including the perceived severity of infections and whether infections lead to concern.Healthcare-seeking behaviour, specifically when infections are considered severe enough to warrant a visit to a healthcare professional.Use of medical treatment prescribed by a healthcare professional in response to an infection.Regional differences in parental and healthcare professional responses to infection occurrence. | — |
Countries
Belgium, Germany, Kuwait, Netherlands, Saudi Arabia, United Arab Emirates
Contacts
Public ContactY.N. Meijer-Krommenhoek
Ausnutria B.V.
Outcome results
None listed