Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant Development
- Sponsor
- Laboratorios Ordesa
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Neurocognitive Development
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Neurocognitive Development
Time Frame: At 2nd, 3rd, 4th, 6th, 12th,18th, 30 th months.
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).
Neurocognitive Development at 4 and 6 years
Time Frame: At 4 and 6 years of age
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).
Neurocognitive Development at 6 years
Time Frame: At 6 years of age
Functional Magnetic Resonance Image
Secondary Outcomes
- Formula Tolerability(At 2nd, 3rd, 4th, 6th, 12th and 18th months.)
- Growth(At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.)
- Incidence of infections(At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.)
- Immunoglobulin A secretor (IgAs) levels(At 3rd, 6th, 12th,18th month, and 4 years old.)
- Impact on microbiota(At 3rd, 6th, 12th and 18th months; 4 and 6 years of age.)
- Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels(At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age.)
- Cardiovascular factors(At 4 and 6 years old)
- Glucose monitoring(At 6 years old)