Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Effects of different inclusions in infant cereals on the number of chews according to the age group.
研究概览
简要总结
The purpose of this study is to define the effects of different inclusions in infant cereals on the adaptation of oral motor behavior and skills displayed at a given age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 6 months (182 days) to 24 months (730 days) of age (from enrollment to last visit):
- •[182-242]-days of age from V1 to last visit for the 6-8-month-old age group 1.
- •[243-364]-days of age from V1 to last visit for the 8-12-month-old age group 1.
- •[365-547]-days of age from V1 to last visit for the 12-18-month-old age group 1.
- •[548-730]-days of age from V1 to last visit for the 18-24-month-old age group
- •Singleton, full-term infants (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- •Healthy children based on medical history as reported by parent(s) / LAR(s).
- •Sit upright with or without support (such as, sitting with back against a chair or while being held) as reported by parent(s) / LAR(s)
- •Keep head steady when in a supported position
- •Have already started complementary feeding as recommended by their health care professional (have started solid food beyond breastmilk or infant formula)
- •Written informed consent is obtained from at least one parent(s) / LAR(s).
- •Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity.
- •Parent(s) / LAR(s) must understand the informed consent and other study documents.
- •Parent(s) / LAR(s) are willing and able to fulfill the requirements of the study protocol within the study timeframe.
排除标准
- •1. Infant's parents or LARs have not reached legal age of majority (18 years)
- •Children with history of oral/facial malformations or surgery (i.e. cleft lip, cleft palate, tongue-tie/ankyloglossia), or history of tube feeding for any reason.
- •3. Children with any chronic illness, congenital malformations (e.g., esophageal or intestinal atresia), surgical sequela (e.g., short bowel syndrome), gastroesophageal reflux disease, behavioral disorders, neurodevelopmental delay or illness that impacts feeding. [children with an acute illness, such as a cold, gastroenteritis etc. can be included but can only attend the visits once they have recovered].
- •4. Children with feeding or swallowing difficulties/disorders, history of choking, or at high risk of choking.
- •5. Child or sibling(s) who has known or suspected food allergy or intolerance, such as cows' milk protein allergy, celiac disease, lactose intolerance, soy allergy, fish allergy, or any other suspected or confirmed food allergies or intolerance.
- •6. Children with undernutrition as determined by age-group weight threshold (based on parental reports): weight at [6-8[month < 6 kg; weight at [8-12[months: < 6.5 kg; weight at [12-18[months: < 7.5 kg; weight at [18-24] months: < 8.5 kg.
- •7. Child is currently participating in or has participated in another intervention clinical study that impacts study outcomes within 4 weeks prior to enrolment or has participated in another age group of this study.
- •8. Family or hierarchical relationships with the research team members.
研究组 & 干预措施
C, D, B, E, A
Cross-over sequence.Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
C, D, B, E, A
Cross-over sequence.Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
A, B, E, C, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
A, B, E, C, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
A, B, E, C, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
A, B, E, C, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
A, B, E, C, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
B, C, A, D, E
Cross-over sequence starting by test product B. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
B, C, A, D, E
Cross-over sequence starting by test product B. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
B, C, A, D, E
Cross-over sequence starting by test product B. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
B, C, A, D, E
Cross-over sequence starting by test product B. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
B, C, A, D, E
Cross-over sequence starting by test product B. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
C, D, B, E, A
Cross-over sequence.Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
C, D, B, E, A
Cross-over sequence.Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
C, D, B, E, A
Cross-over sequence.Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
D, E, C, A, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
D, E, C, A, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
D, E, C, A, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
D, E, C, A, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
D, E, C, A, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
E, A, D, B, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
E, A, D, B, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
E, A, D, B, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
E, A, D, B, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
E, A, D, B, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
D, C, E, B, A
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
D, C, E, B, A
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
D, C, E, B, A
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
D, C, E, B, A
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
D, C, E, B, A
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
E, D, A, C, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
E, D, A, C, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
E, D, A, C, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
E, D, A, C, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
E, D, A, C, B
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
A, E, B, D, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
A, E, B, D, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
A, E, B, D, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
A, E, B, D, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
A, E, B, D, C
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
B, A, C, E, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
B, A, C, E, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
B, A, C, E, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
B, A, C, E, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
B, A, C, E, D
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
C, B, D, A, E
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: A (Other)
C, B, D, A, E
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: B (Other)
C, B, D, A, E
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: C (Other)
C, B, D, A, E
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: D (Other)
C, B, D, A, E
Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.
干预措施: E (Other)
结局指标
主要结局
Effects of different inclusions in infant cereals on the number of chews according to the age group.
时间窗: Immediately after the product intake
Define the change in number of chews observed during consumption of infant cereals with or without different inclusions based on manual video coding
次要结局
- Impact of inclusions on food liking during consumption of infant cereals according to age group.(Immediately after the product intake)
- Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.(Immediately after the product intake)
- Associations between inclusion properties and oral motor movement according to age group.(Immediately after the product intake)
- Impact of inclusions on food acceptance during consumption of infant cereals according to age group.(Immediately after the product intake)