The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.
Nowadays, almost all commercial infant formulas resemble the "gold standard" of breast milk in terms of composition of essential nutrients, but it is still a challenge to identify and incorporate certain bioactive components capable of replicating those stimuli typical of breast milk that can program growth, infant development and maturation of the immune system. The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life. In addition, considering that the quality of feeding at these early ages will program (Early programming) the health and physiology of the child and the future adult, the study wants to obtain evidence of the effects of this new infant formula on the immune system and the development of the child compared to breast milk during the first year of life, hoping that it promotes proper growth, adequate cognitive development and maturation of the immune system as similar as possible to children fed to the mother's breast.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
231
Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics
Infants receiving a standard infant formula.
Infants exclusively or predominantly breastfed (\>75%).
Cristina Campoy
Granada, Andalusia, Spain
RECRUITINGRegister of infections
Register of infant infections through patient diaries completed by parents
Time frame: From baseline to 12 months
Register of fever episodes
Presence and duration of the fever and treatments, through diaries completed by parents
Time frame: From baseline to 12 months.
Register of diarrhea episodes
Presence and duration of diarrhea, registered in patients dairies.
Time frame: From baseline to 12 months.
Immune response evaluation
registration of Immunoglobulin secreted in saliva
Time frame: At 3, 6 and 12 months of age
Demographic data
age of the parents, educational level of the parents, habits and lifestyles of the parents, residence and social environment of the infant.
Time frame: From baseline to 12 months.
Obstetric background
Relevant obstetric background
Time frame: Baseline
Study of the infant microbiota
Stool bacteria count
Time frame: At 3, 6 and 12 months.
Assessment of normal growth of the infant
Evolution of Weight (g), Size (cm) to calculate the Body Mass Index.weight and height will be combined to report BMI in kg/m\^2
Time frame: From baseline to 12 months.
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Infant neurodevelopment
Analysis of eye movements. Eye tracking technologies is using to assess early cognitive development to evaluate attention domain
Time frame: At 12 months
Infant neurodevelopment 2
ASQ-3 (Ages \& Stages Questionnaires®) ASQ-3 is a set of questionnaires about children's development
Time frame: At 2, 3, 4, 6, 9 and 12 months of age.
Infant neurodevelopment 3
General Movements test (GM´s) GM's is using for the neurological assessment during the first months of life and measures a series of gross movements of variable amplitude and speed involving all body parts
Time frame: At 2, 3 and 4 months of life.
Infant neurodevelopment 4
Bayley´s Scales of Infant Development III (Spanish version BSID III) is using to evaluate psychomotor and mental development .
Time frame: 6 and 12 months of age
Infant neurodevelopment 5
MacArthur Communicative Development Inventory (CDI) . This test assesses the normal process of early language acquisition by various manifestations
Time frame: 12 months of age