NCT04766346已完成不适用
Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns: a Prospective, Single-arm, Open-label, Interventional Study
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年2月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.
时间窗: Day 1 to Day 113
The primary endpoint is the change in weight-for-length/height z-score
次要结局
- Sub-scapular skinfold thickness(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
- Suprailiac skinfold thickness(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
- Weight(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
- Length/height(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
- BMI(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
- Triceps skin fold thickness(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
- Z scores and percentiles(Day 1, Day 22, Day 43, Day 64, Day 85, Day 113)
- Nutrient intake(Day 22, Day 43, Day 113)
- Temperament and behavior(Day 1, Day 113)
- Learning skills(Day 1, Day 113)
- Child and parent well-being reported from the parents' perspective(Day 1, Day 113)
- Product acceptance(Day 22, Day 64, Day 113)
- Product acceptance including child-liking and post-ingestive effects(Day 22, Day 64, Day 113)
研究者
研究点 (2)
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