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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
220
New infant formula
Standard infant formula
Exclusive breastfeeding or less tan 25% formula intake
Facultad de Medicina
Granada, Spain
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).
Time frame: 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).
Time frame: At 4 and 6 years of age
Neurocognitive Development at 6 years
Functional Magnetic Resonance Image
Time frame: At 6 years of age
Formula Tolerability
Evaluation of gastrointestinal symptoms and sleep disorders amongst groups.
Time frame: 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.
Time frame: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
Incidence of infections
Number of infections reported.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age.
Cardiovascular factors
Blood pressure measurement
Time frame: At 4 and 6 years old
Glucose monitoring
Urine metabolomic analysis
Time frame: At 6 years old