Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Neurocognitive Development
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
New infant formula
New infant formula with key ingredients.
干预措施: New infant formula (Dietary Supplement)
Standard infant formula
Standard infant formula
干预措施: Standard infant formula (Dietary Supplement)
Breastfeeding
Control
干预措施: Breastfeeding (Dietary Supplement)
结局指标
主要结局
Neurocognitive Development
时间窗: 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
时间窗: 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
时间窗: At 6 years of age
Functional Magnetic Resonance Image
次要结局
- 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)