Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns

Study Overview
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Brief Summary
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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.

Official Title
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Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns: a Prospective, Single-arm, Open-label, Interventional Study

Conditions
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Growth, Learning, Toddlers

Intervention / Treatment
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* Other: Fortified Cow's Milk-Based Oral Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Evidence of a personally signed and dated informed consent document indicating that the child's parent(s) / legally acceptable representative (LAR) has been informed of all pertinent aspects of the study. Child was full-term at birth (i.e., ≥ 37 completed weeks of gestation with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg). Child is age 12 - 36 months and generally healthy (acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot & mouth disease at time of enrolment is permitted). Children whose parents show some concern about their child's growth, such as child is too thin for his or her length/height, child has experienced recent rapid weight loss or failure to gain weight or length/height, or child's growth curve shows a downward trajectory of growth velocity Child has a weight-for-length/height ≤ 25th percentile as per WHO growth charts. Parents agree to feed their child a nutritional supplement in addition to normal diet. Child's parent(s) / guardian can be contacted directly by telephone or email throughout the study. Child's parent is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol. EXCLUSION CRITERIA Child is currently breastfed or is consuming breast milk Child has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that impact diet. Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded Child has chronic illness or other disease including any condition that impacts feeding or growth Child having any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g., short bowel syndrome) potentially affecting feeding or growth Child has been diagnosed with Infantile anorexia nervosa Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study. Child or child's parent(s) not willing and/or not able to comply with scheduled visits and the requirements of the study protocol. Child of any investigational site staff member or Nestlé employee directly involved in the conduct of the trial. Child is currently participating in or has participated in another clinical trial within 4 weeks prior to enrolment.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Supplement<br>The NS is a fortified cow's milk-based product provided in powdered form. | Other: Fortified Cow's Milk-Based Oral Nutritional Supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 1 to Day 113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measurement of Weight in grams | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 | 
| Length/height | Measurement of length/height in cms | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 | 
| Triceps skin fold thickness | Measurement of triceps skinfold thickness | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 | 
| Sub-scapular skinfold thickness | Measurement of sub-scapular skinfold thickness in mm | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 | 
| Suprailiac skinfold thickness | Measurement of suprailiac skinfold thickness in mm | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 | 
| BMI | BMI will be calculated and expressed in Kg/m2 | 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 | 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 | 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) | 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. | 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. | Day 1, Day 113 | 
| Product acceptance | Product acceptance scores from the Toddler Milk Satisfaction Questionnaire | 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 | Day 22, Day 64, Day 113 |