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

Overview

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.

Full Title of Study: “Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2016

Interventions

  • Dietary Supplement: New infant formula
    • New infant formula
  • Dietary Supplement: Standard infant formula
    • Standard infant formula
  • Dietary Supplement: Breastfeeding
    • Exclusive breastfeeding or less tan 25% formula intake

Arms, Groups and Cohorts

  • Experimental: New infant formula
    • New infant formula with key ingredients.
  • Active Comparator: Standard infant formula
    • Standard infant formula
  • Other: Breastfeeding
    • Control

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Formula Tolerability
    • Time Frame: At 2nd, 3rd, 4th, 6th, 12th and 18th months.
    • Evaluation of gastrointestinal symptoms and sleep disorders amongst groups.
  • Growth
    • Time Frame: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
    • Differences in growth parameters (weight, length, BMI, skin folds, perimeters and z-scores) between groups.
  • Incidence of infections
    • Time Frame: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
    • Number of infections reported.
  • Immunoglobulin A secretor (IgAs) levels
    • Time Frame: At 3rd, 6th, 12th,18th month, and 4 years old.
    • Inter and intragroup differences measured by saliva samples analysis.
  • Impact on microbiota
    • Time Frame: At 3rd, 6th, 12th and 18th months; 4 and 6 years of age.
    • Changes in microbiota composition measured by real-time polymerase chain reaction (RT-PCR) in faeces.
  • Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels
    • Time Frame: At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age.
    • Differences in LC-PUFAS levels inter and intragroup evaluated by oral mucosa samples analysis.
  • Cardiovascular factors
    • Time Frame: At 4 and 6 years old
    • Blood pressure measurement
  • Glucose monitoring
    • Time Frame: At 6 years old
    • Urine metabolomic analysis

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 60 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Laboratorios Ordesa
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cristina Campoy, Professor, Principal Investigator, Universidad de Granada

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