Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04766346
Other study ID # 20.09.INF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 26, 2021
Est. completion date October 27, 2022

Study information

Verified date November 2022
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date October 27, 2022
Est. primary completion date August 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 3 Years
Eligibility INCLUSION CRITERIA 1. 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. 2. 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). 3. 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). 4. 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 5. Child has a weight-for-length/height = 25th percentile as per WHO growth charts. 6. Parents agree to feed their child a nutritional supplement in addition to normal diet. 7. Child's parent(s) / guardian can be contacted directly by telephone or email throughout the study. 8. 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 1. Child is currently breastfed or is consuming breast milk 2. 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. 3. Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded 4. Child has chronic illness or other disease including any condition that impacts feeding or growth 5. Child having any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g., short bowel syndrome) potentially affecting feeding or growth 6. Child has been diagnosed with Infantile anorexia nervosa 7. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study. 8. Child or child's parent(s) not willing and/or not able to comply with scheduled visits and the requirements of the study protocol. 9. Child of any investigational site staff member or Nestlé employee directly involved in the conduct of the trial. 10. Child is currently participating in or has participated in another clinical trial within 4 weeks prior to enrolment.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fortified Cow's Milk-Based Oral Nutritional Supplement
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.

Locations

Country Name City State
Philippines Las Piñas Doctors Hospital Las Piñas

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety assessment Data from standard AE reporting (including common illnesses) for safety assessment from date of ICF signing through 30 days after the last day of NS intake. Day -7 to Day 113 + 30
Other Sick days Total number of sick days Day -7 to Day 113 + 30
Other Concomittant medications and treatment All concomitant medications / treatments used to treat illnesses and other conditions will be recorded (both dose and duration) through 30 days after the last day of NS intake. Day -7 to Day 113 + 30
Primary 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 Weight Measurement of Weight in grams Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Secondary Length/height Measurement of length/height in cms Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Secondary Triceps skin fold thickness Measurement of triceps skinfold thickness Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Secondary Sub-scapular skinfold thickness Measurement of sub-scapular skinfold thickness in mm Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Secondary Suprailiac skinfold thickness Measurement of suprailiac skinfold thickness in mm Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Secondary BMI BMI will be calculated and expressed in Kg/m2 Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Product acceptance Product acceptance scores from the Toddler Milk Satisfaction Questionnaire Day 22, Day 64, Day 113
Secondary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05551975 - Preterm Infants Fed a Human Milk Fortifier N/A
Completed NCT01721512 - The Growth and Development of Breast and Formula Fed Term Asian Infants N/A
Completed NCT01162798 - Preterm Infant Growth N/A
Active, not recruiting NCT00970398 - Effect of an Infant Formula on Infant Growth, Health and Immune Functions N/A
Completed NCT01666457 - Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
Completed NCT00808756 - Study on Fermentable Carbohydrates in Healthy Infants N/A
Completed NCT00997971 - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein Phase 3
Completed NCT03276663 - Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula N/A
Recruiting NCT02695784 - Probiotics After Discharge Phase 4
Withdrawn NCT02860026 - Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas N/A
Completed NCT01128517 - Maternal Education on Complementary Feeding and Infant Outcome N/A
Completed NCT00282113 - Effects of Probiotic and Prebiotic Combinations on Premature Infants N/A
Completed NCT03276884 - Growth and Tolerance of Young Infants N/A
Completed NCT04055363 - Human Milk Oligosaccharides (HMOs) Post-market Study on Infants N/A
Completed NCT05302427 - Infant Massage and Infant Growth, Mother-Infant Attachment, and Maternal Self-Confidence N/A
Not yet recruiting NCT05616117 - Next-generation Effects of Vitamin D Supplementation in Pregnancy
Active, not recruiting NCT02410057 - Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula N/A
Completed NCT01109849 - Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth Phase 4
Completed NCT01210391 - Growth of Infants Fed an Extensively Hydrolyzed Infant Formula N/A
Completed NCT01158352 - Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children N/A