Effect of cow’s milk infant formula on neurodevelopment and growth in infants

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: The intervention products are infant formula for 0‐6 month‐old infants and follow‐on formula for 6‐12 month‐old infants. All products comply with GB standard for nutritional composition. Healthy term infants in group 1 receive a infant formula and follow‐on formula enriched in complex milk lipids to match the upper end of breast milk levels. Composition of the infant formula products for group 1 per 100 mL of reconstituted powder formula (67 kcal/100 mL): Protein 1.7 g, fat 3.4 g, carbohydrate (lactose) 7.4 g, linoleic acid 400 mg, a‐linolenic acid 45 mg, prebiotic, probiotic, vitamins and minerals. Composition of the follow‐on formula products for group 1 per 100 kcal of reconstituted powder formula (68 kcal/100 mL): Protein 2.2 g, fat 3.2 g, carbohydrate (lactose) 7.8 g, linoleic acid 360 mg, prebiotic, probiotic, vitamins and minerals. Up to 2 weeks of age, infants will be fed 7‐8 times 60 mL of formula by their parent or caregiver at home. Up to 4 weeks of age, infants will be fed 7‐8 times 90 mL of formula by their parent or caregiver at home. Up to 2 months of age, infants will be fed 6‐7 times 120 mL of formula by their parent or caregiver at home. Up to 4 months of age, infants will be fed 5‐6 times 150 mL of formula by their parent or caregiver at home. Up to 6 months of age, infants will be fed 5‐6 times 180 mL of formula by their parent or caregiver at home. Between 6 and 12 months of age, infants will be fed 3‐4 times 210 mL of formula by their parent or caregiver at home. It is expected that weaning foods will be introduced from 6 months. All infant feeding will be monitored by every scheduled visit, we also will collect and record number of empty cans of formula milk from each infant’s parent throughout the trial. CONDITION: Brain Development in term infants Infant nutrition PRIMARY OUTCOME: Neurodevelopment ; The Bayley Scales of Infant and Toddler Development (Bayley II or III) will be used to test neurodeveloping and cognitive function ability of infants. SECONDARY OUTCOME: Growth assessed by anthropometry measurements Gut microbiota, assessed by faecal sample metagenomic sequencing. Neurodevelopment ; ; The Bayley Scales of Infant and Toddler Development (Bayley II or III) will be used to test neurodeveloping and cognitive function ability of infants. Short term memory (Chinese version) ; ; The Bayley Scales of Infant and Toddler Development (Bayley II or III) will be used to test neurodeveloping and cognitive function ability of infants. formula tolerance assessed by feeding survey. This survey was designed for this study. INCLUSION CRITERIA: Healthy full term infants, born at gestational age between 35 and 41 weeks and with a birth body weight between 2500 and 4000 g
Epistemonikos ID: 56f860025952751eb722189ae47834001575ae39
First added on: Aug 25, 2024