1,000
Participants
Start Date
July 31, 2025
Primary Completion Date
December 31, 2030
Study Completion Date
March 31, 2031
Cow's milk formula [CMF]
At least 10 ml daily of cow's milk formula (Bebiko 1 NUTRIFlor Expert®, Nutricia; formula with galactooligosaccharides and without probiotics); and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.
Amino-acid formula [AAF]
At least 10 ml daily of amino-acid formula (Nutramigen Pureamino®, Reckitt Benckiser Group PLC); and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.
Donor human milk [DHM]
At least 10 ml daily of donor human milk; and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.
"High-pressure processed pascalized donor human milk [DHM-P]"
"At least 10 ml daily of high-pressure processed pascalized donor human milk; and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided."
Medical University of Warsaw, Warsaw
Collaborators (1)
Medical Research Agency, Poland
OTHER_GOV
Medical University of Warsaw
OTHER