Status:
COMPLETED
Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Growth
Learning
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04766346
Start Date
February 26 2021
End Date
October 27 2022
Last Update
November 28 2022
Active Locations (1)
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1
Las Piñas Doctors Hospital
Las Piñas, Philippines, 1742