Human Milk Oligosaccharides (HMOs) - Post Marketing Study on Infants (NeHMO)

Objectives: The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting. Main endpoints: 1. Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards 2. Feeding tolerance assessed via monitoring parent-reported overall GI symptom burden measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score (13-item summary score) Additional objectives: To describe the following outcomes in infants fed an infant formula supplemented with HMOs: 1. Formula acceptability 2. Despite there are no expected safety concerns, standard Adverse Events (AEs) monitoring will be implemented during the study Additional endpoints: 1. Formula acceptability assessed by the Study Formula Satisfaction Questionnaire 2. Reported AEs and Serious Adverse Events (SAEs) including type, incidence, severity, seriousness and relation to study formula consumption as well as concomitant medications and non-pharmacological treatments. * Select morbidities of interest (i.e., respiratory illnesses, GI illnesses, and fever) will be collected as part of AE reporting and specific corresponding AE guidance forms will be used to standardize reporting of such AEs Trial design: Uncontrolled, single arm, open-label, prospective study in infants (enrolled at postnatal age 7 days to 2 months) fed the study formula for 8 weeks (56 days) Trial population: Healthy, male and female, term infants, 7 days postnatal age to 2 months of age at the enrollment Treatment duration: Total study participation/intervention up to approximately 8 weeks