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| Name | Class |
|---|---|
| Universidad de Granada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enriched infant formula | Experimental | Infant formula enriched with dairy ingredients: osteopontin, prebiotics (Human milk oligosaccharide, Glucooligosaccharides) and probiotics. |
|
| Standard formula | Active Comparator | Infants receiving a standard infant formula. |
|
| Breastfeeding arm | Active Comparator | Infants exclusively or predominantly breastfed (>75%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enriched infant formula | Dietary Supplement | Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics |
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| Measure | Description | Time Frame |
|---|---|---|
| Register of infections | Register of infant infections through patient diaries completed by parents | From baseline to 12 months |
| Register of fever episodes | Presence and duration of the fever and treatments, through diaries completed by parents | From baseline to 12 months. |
| Register of diarrhea episodes | Presence and duration of diarrhea, registered in patients dairies. | From baseline to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response evaluation | registration of Immunoglobulin secreted in saliva | 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. |
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Inclusion Criteria:
Additional Inclusion Criteria for groups 1 and 2:
Additional Inclusion Criteria for group 3 (breastfeed infants):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roser De Castellar, MD | Contact | 902 10 52 43 | roser.decastellar@ordesa.es | |
| Cristina Campoy, MD | Contact | +34629308695 | ccampoy@ugr.es |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Campoy, MD | EURISTIKOS Excellence Centre for Paediatric Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cristina Campoy | Recruiting | Granada | Andalusia | 18016 | Spain |
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| Standard formula | Dietary Supplement | Infants receiving a standard infant formula. |
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| Breastfeeding arm | Dietary Supplement | Infants exclusively or predominantly breastfed (>75%). |
|
| From baseline to 12 months. |
| Obstetric background | Relevant obstetric background | Baseline |
| Study of the infant microbiota | Stool bacteria count | 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 | From baseline to 12 months. |
| Infant neurodevelopment | Analysis of eye movements. Eye tracking technologies is using to assess early cognitive development to evaluate attention domain | At 12 months |
| Infant neurodevelopment 2 | ASQ-3 (Ages & Stages Questionnaires®) ASQ-3 is a set of questionnaires about children's development | 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 | 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 . | 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 | 12 months of age |