This open-label clinical trial will gain evidence of the effect of an oral Nutritional Supplement (NS) to help improve catch-up growth and support learning skills in children with growth concerns.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
168
The NS is a fortified cow's milk-based product provided in powdered form that provides the appropriate amount of energy and protein to promote growth in children.
Las Piñas Doctors Hospital
Las Piñas, Philippines
The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.
The primary endpoint is the change in weight-for-length/height z-score
Time frame: Day 1 to Day 113
Weight
Measurement of Weight in grams
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Length/height
Measurement of length/height in cms
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Triceps skin fold thickness
Measurement of triceps skinfold thickness
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Sub-scapular skinfold thickness
Measurement of sub-scapular skinfold thickness in mm
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Suprailiac skinfold thickness
Measurement of suprailiac skinfold thickness in mm
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
BMI
BMI will be calculated and expressed in Kg/m2
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Z scores and percentiles
1\) Sex-age-specific weight, length/height, BMI and triceps and subscapular skinfold thickness percentiles and Z-scores calculated according to WHO standards. 2) Changes from baseline in sex-age-specific percentiles and Z-scores
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Nutrient intake
Nutrient intake from 3-day Food Intake Diaries that will be completed at home for two weekdays and 1 weekend day
Time frame: Day 22, Day 43, Day 113
Learning skills
Learning Scores derived from the Ages and Stages Questionnaire, Third Edition (ASQ-3) (with a focus on communication and problem-solving skills)
Time frame: Day 1, Day 113
Temperament and behavior
Temperament and behaviour scores from the Early Childhood Behavior Questionnaire- Short Form (ECBQ-SF) completed. The ECBQ-SF has 107 questions and assesses dimensions of temperament such as activity Level/Energy, attentional Focusing, attentional Shifting, cuddliness, discomfort, fear, frustration, high-intensity Pleasure, impulsivity, inhibitory Control, low-intensity Pleasure, motor Activation, perceptual Sensitivity, positive Anticipation, sadness, shyness, sociability and soothability.The scale items ask parents to report on the frequency of specific behaviours in frequently occurring contexts on a 7 point likert scale ranging from never to always.
Time frame: Day 1, Day 113
Child and parent well-being reported from the parents' perspective
Child health-related quality of life scores assessed using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). The ITQOL-SF47 has 47 questions and assesses domains such as the overall health, physical abilities, growth and development, bodily pain/discomfort, temperament and moods, general health perceptions, parent impact - emotional, parent impact - time and family cohesion with a score of 0 (worst) to 100 (best) for each of these domains.
Time frame: Day 1, Day 113
Product acceptance
Product acceptance scores from the Toddler Milk Satisfaction Questionnaire
Time frame: Day 22, Day 64, Day 113
Product acceptance including child-liking and post-ingestive effects
Primary facial expression valence and child heart rate variability derived from the ANURA for Research (smartphone app) while child is consuming one serving of the NS
Time frame: Day 22, Day 64, Day 113