The purpose of this study is to demonstrate the efficacy of the nutrient blend in a starter infant formula (IF) and follow up infant formula (FUF) in improving the neurocognitive and behavioural outcomes among formula-fed infants randomized to the experimental formula (EF) versus the control formula (CF).
This is a prospective, randomized, controlled, double-blind, 2-arm parallel-group clinical trial in the Philippines. Subjects will be recruited from a single centre; in case of insufficient recruitment, more sites will be added to the study. The clinical trial is composed of two parts: a double-blind interventional period and a follow-up period. The first period is the double-blind intervention phase from enrolment (V1) until age 12 months (V5). The intervention will be provided only during this double-blind phase. The second period is a non-interventional follow-up period from age 12 months until age 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
240
Cow's milk-based infant formula with a specific blend of nutrients at pre-defined levels
Cow's milk-based infant formula with standard nutritional composition
Las Piñas Doctors Hospital
Las Piñas, Philippines
Scores on the Cognitive subscale of the Bayley Scale of Infant Development, 4th Edition
Change in the scores on the Cognitive subscale. The scores range from 40 to 160 and higher scores indicate a better cognitive outcome
Time frame: 12 months
Infant Global developmental status in all domains of the Bayley Scale of Infant Development, 4th Edition
Infant Language, motor, socio-emotional, adaptive behaviour, and cognitive scores will be assessed
Time frame: 6 months, 9 months, 12 months, and 24 months
Infant Visual attention
Developmental status of infants' visual attention will be assessed using the infant Gap-Overlap task
Time frame: 4 months, 6 months, 9 months, and 12 months
Infant Visual learning
Infant's quality of attention will be assessed using the infant visual habituation task as augmented with heart rate
Time frame: 4 months, 6 months, 9 months, and 12 months
Early language development
Assessed using the MacArthur-Bates Communicative Development Inventories
Time frame: Words and Gestures (long form) at 12 months and Words and Sentences (long form) at 24 months
Working memory and inhibitory control
Assessed using the A-not-B Invisible Displacement Task
Time frame: 24 months
Behavioral manifestations of executive function
Assessed using the Behavior Rating Inventory of Executive Function-Preschool version. The questionnaire consists of scales such as Inhibit, Shift, Emotional Control, working memory, plan and organize and Indexes such as Inhibitory Self control, Flexibility Index, Emergent metacognition index and Global Executive Composite. T scores are used to interpret the child's level of executive functioning on the BRIEF-P. scores provide information about a child's scores relative to the scores of children in the standardization sample
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Time frame: 24 months
Infant temperament
Assessed using the Infant Behaviour Questionnaire Revised Short Form. The questionnaire assess dimensions of temperament along 14 scales on a 7-point Likert scale on behavior occurrence, with 1 being never and 7 being always (Activity level, Distress to limitations, Approach, Fear, Duration of orienting, smiling and laughter, vocal reactivity, Sadness, Perceptual sensitivity, High-intensity pleasure, Low-intensity pleasure, Cuddliness, Soothability, Falling Reactivity/Rate of Recovery From Distress)
Time frame: 1.5-2 months, 6 months, and 12 months
Child temperament
Child temperament will be assessed using the Early Childhood Behavior Questionnaire- Short Form. The questionnaire measures 18 discrete traits embedded within three higher-order factors on a 7-point Likert scale on behavior occurrence, with 1 being never and 7 being always. Negative Affect (Discomfort, Fear, Frustration, Motor Activation, Sadness, Perceptual Sensitivity, Shyness, Soothability), Surgency (Impulsivity, Activity Level, High Intensity Pleasure, Sociability, Positive Anticipation), and Effortful Control (Inhibitory Control, Attention Shifting, Low Intensity Pleasure, Cuddliness, and Attentional Focusing).
Time frame: 24 months
Infant sleep
Infant daytime and night-time sleep patterns, parent perception, and sleep-related behaviours will be assessed using the Brief Infant Sleep Questionnaire
Time frame: 1.5-2 months, 6 months, 12 months, and 24 months
Infant fecal microbiota
Overall fecal microbiota composition, diversity, microbiota community types will be assessed using next generation sequencing (NGS) technology
Time frame: 1.5-2 months (but before starting study formula), and just prior to 6 months, and 12 months
Infant immune and gut health biomarkers
Fecal markers of immune and gut barrier, such as but no restricted to total secretory IgA (sIgA), lipocalin-2, calprotectin, and α-1-antitrypsin will be assessed by ELISA
Time frame: 1.5-2 months (but before starting study formula), 6 months, and 12 months