A Neurocognitive and Immunological Study of a New Formula for Healthy Infants

Study Overview
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Brief Summary
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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.

Official Title
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Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes

Conditions
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Infant Development

Intervention / Treatment
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* Dietary Supplement: New infant formula
* Dietary Supplement: Standard infant formula
* Dietary Supplement: Breastfeeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full-term newborns (>37 weeks and <41 weeks gestation) Adequate birth weight for his gestational age (between 3-97 percentiles) Inclusion age: from 0 to 2 months (60 days) in the formula fed groups Inclusion age: 2-6 months (180 days) in the breastfeeding group Maximum 30 days of exclusive breastfeeding in the formula fed groups From 30 days on, exclusive or >70% infant formula in the formula fed groups Normal Apgar score: 7-10 Umbilical pH ≥ of 7.10 Availability to continue during the whole study period Informed consent signed ( parent/legal representative) Exclusion Criteria: Participating in other studies. Nervous system disorders (hydrocephalic, perinatal hypoxia, intraventricular hemorrhage, neonatal meningitis, septic shock, West Sd...). Gastrointestinal disorders (cow's milk protein allergy, lactose intolerance) Mother's disease history or during pregnancy: neurological and metabolic diseases, diabetes mellitus type 1, hypothyroidism, undernutrition, infections TORCH complex. Mothers receiving anxiolytic or antidepressant treatment during pregnancy or other potentially harmful drug treatments for infants' neurodevelopment. Infant's family who in the investigators assessment cannot be expected to comply with the protocol.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 60 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New infant formula<br>New infant formula with key ingredients. | Dietary Supplement: New infant formula<br>* New infant formula<br>|
| Active Comparator: Standard infant formula<br>Standard infant formula | Dietary Supplement: Standard infant formula<br>* Standard infant formula<br>|
| Other: Breastfeeding<br>Control | Dietary Supplement: Breastfeeding<br>* Exclusive breastfeeding or less tan 25% formula intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Formula, Cognition, Neurodevelopment, Immunity, Microbiota