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To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New infant formula | Experimental | New infant formula with key ingredients. |
|
| Standard infant formula | Active Comparator | Standard infant formula |
|
| Breastfeeding | Other | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New infant formula | Dietary Supplement | New infant formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive Development | Differences in neurocognitive development inter and intragroup evaluated by visual evoked potential test, general movements test, BAYLEY'S III test, MacArthur test, behavior assessment and cognitive evoked potential test (EEG/ERP). | At 2nd, 3rd, 4th, 6th, 12th,18th, 30 th months. |
| Neurocognitive Development at 4 and 6 years | Differences in neurocognitive development evaluated by Computarized battery for neuropsychological evaluation of children, Kaufman Brief Intellligence Test, Language test of Navarre,functional exploration, behavior assessment, questionnaires and cognitive evoked potential test (EEG/ERP). | At 4 and 6 years of age |
| Neurocognitive Development at 6 years | Functional Magnetic Resonance Image | At 6 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Formula Tolerability | Evaluation of gastrointestinal symptoms and sleep disorders amongst groups. | At 2nd, 3rd, 4th, 6th, 12th and 18th months. |
| Growth | Differences in growth parameters (weight, length, BMI, skin folds, perimeters and z-scores) between groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary assessment | Food frequency questionnaires and 24 h food recalls. | At 6th, 12th and 18th months; 2.5, 4 and 6 years. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Campoy, Professor | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de Medicina | Granada | 18071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36313089 | Derived | Dieguez E, Nieto-Ruiz A, Martin-Perez C, Sepulveda-Valbuena N, Herrmann F, Jimenez J, De-Castellar R, Catena A, Garcia-Santos JA, Bermudez MG, Campoy C. Association study between hypothalamic functional connectivity, early nutrition, and glucose levels in healthy children aged 6 years: The COGNIS study follow-up. Front Nutr. 2022 Oct 12;9:935740. doi: 10.3389/fnut.2022.935740. eCollection 2022. | |
| 35777109 |
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| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
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| Standard infant formula |
| Dietary Supplement |
Standard infant formula |
|
| Breastfeeding | Dietary Supplement | Exclusive breastfeeding or less tan 25% formula intake |
|
| At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6. |
| Incidence of infections | Number of infections reported. | At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6. |
| Immunoglobulin A secretor (IgAs) levels | Inter and intragroup differences measured by saliva samples analysis. | At 3rd, 6th, 12th,18th month, and 4 years old. |
| Impact on microbiota | Changes in microbiota composition measured by real-time polymerase chain reaction (RT-PCR) in faeces. | At 3rd, 6th, 12th and 18th months; 4 and 6 years of age. |
| Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels | Differences in LC-PUFAS levels inter and intragroup evaluated by oral mucosa samples analysis. | At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age. |
| Cardiovascular factors | Blood pressure measurement | At 4 and 6 years old |
| Glucose monitoring | Urine metabolomic analysis | At 6 years old |
| Derived |
| Cerdo T, Ruiz A, Acuna I, Nieto-Ruiz A, Dieguez E, Sepulveda-Valbuena N, Escudero-Marin M, Garcia-Santos JA, Garcia-Ricobaraza M, Herrmann F, Moreno-Munoz JA, De Castellar R, Jimenez J, Suarez A, Campoy C. A synbiotics, long chain polyunsaturated fatty acids, and milk fat globule membranes supplemented formula modulates microbiota maturation and neurodevelopment. Clin Nutr. 2022 Aug;41(8):1697-1711. doi: 10.1016/j.clnu.2022.05.013. Epub 2022 May 23. |
| 35356726 | Derived | Nieto-Ruiz A, Garcia-Santos JA, Verdejo-Roman J, Dieguez E, Sepulveda-Valbuena N, Herrmann F, Cerdo T, De-Castellar R, Jimenez J, Bermudez MG, Perez-Garcia M, Miranda MT, Lopez-Sabater MC, Catena A, Campoy C. Infant Formula Supplemented With Milk Fat Globule Membrane, Long-Chain Polyunsaturated Fatty Acids, and Synbiotics Is Associated With Neurocognitive Function and Brain Structure of Healthy Children Aged 6 Years: The COGNIS Study. Front Nutr. 2022 Mar 9;9:820224. doi: 10.3389/fnut.2022.820224. eCollection 2022. |
| 33602357 | Derived | Sepulveda-Valbuena N, Nieto-Ruiz A, Dieguez E, Herrmann F, Escudero-Marin M, De-Castellar R, Rodriguez-Palmero M, Miranda MT, Garcia-Santos JA, Bermudez MG, Campoy C. Growth patterns and breast milk/infant formula energetic efficiency in healthy infants up to 18 months of life: the COGNIS study. Br J Nutr. 2021 Dec 28;126(12):1809-1822. doi: 10.1017/S000711452100057X. Epub 2021 Feb 19. |