Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants: a Randomized, Controlled, Intervention Study

Change in the scores on the Cognitive subscale. The scores range from 40 to 160 and higher scores indicate a better cognitive outcome

Infant Language, motor, socio-emotional, adaptive behaviour, and cognitive scores will be assessed

Developmental status of infants' visual attention will be assessed using the infant Gap-Overlap task

Infant's quality of attention will be assessed using the infant visual habituation task as augmented with heart rate

Assessed using the MacArthur-Bates Communicative Development Inventories

Assessed using the A-not-B Invisible Displacement Task

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

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)

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).

Infant daytime and night-time sleep patterns, parent perception, and sleep-related behaviours will be assessed using the Brief Infant Sleep Questionnaire

Overall fecal microbiota composition, diversity, microbiota community types will be assessed using next generation sequencing (NGS) technology

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

Assessed using Infant Gastrointestinal Symptom Questionnaire. The questionnaire comprises of 13 questions assessed on a 5-point Likert Scale with overall scores of 13 (best) to 65 (worst) for overall GI symptoms

Assessed using Toddler Gut Comfort Questionnaire. The questionnaire comprises of 10 questions assessed on a 6-point scale for frequency and severity, ranging from 1 (None or Not at all) to 6 (Always or Very strong).

Head circumference measured in cm

Weight measured in grams

Length/Height measured in cm

Weight and height will be combined to report BMI in kg/m2

Weight-for-age, height-for-age, weight-for-height, head circumference-for-age, BMI-for-age, weight and height velocity

Collected as part of standard adverse events reporting for safety assessment including medication use and paper Infant Illness Diary continuously from enrolment until V5 (12 mo).

Assessed using Study Compliance Diary

Will be assessed using a 24-hour Dietary Recall completed by the parent / caregiver

Assessed using an Edinburgh Postnatal Depression Scale. The questionnaire comprises of 10 questions. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is obtained by adding together the scores for each of the 10 items. Scores above 12 or 13 are likely to be indicative of possible depression

Assessed using a Parenting Stress Index-Short Form. The questionnaire comprises of thirty-six items divided into three domains: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC), which combine to form a Total Stress scale. Each subscale consists of 12 items rated from 1 (strongly disagree) to 5 (strongly agree), with subscales scores ranging from 12 to 60. A Total score is calculated by summing the three subscales scores, ranging from 36 to 180. Scores of 90 or above may indicate a clinical level of stress.