Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
The goal of this study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC.
详细描述
Rationale: The definition of FG/FTT was established by a group of experts in a report published in 2023 (Cooke et al., 2023). In this report they agreed a fall in weight-for-age z-score (WAZ) of ≥1.0 SD over a period of 1 or more months (excluding the first 2 weeks after birth) which includes at least 2-3 growth measurements (Cooke et al., 2023). It is also important to consider infants at risk who have static weight for extended periods e.g., >/=4 weeks. FG/FTT affects different populations and is estimated to be 10% of infants globally.
InfaCore (IC) an energy and nutrient dense formulation is indicated for infants and young children with FG/FTT defined above or for those at risk of developing e.g., with static weight for extended periods. At risk infants might include some or all of the following those with congenital heart disease (CHD) admitted for surgical procedures, those with critical illness (CI) or on the PICU, infants cystic fibrosis (CF) or other respiratory conditions including chronic lung disease (CLD), some forms of severe cerebral palsy (CP), and those requiring a surgical procedure or post-surgery.
Objective
To demonstrate growth and tolerance in infants with or at risk of growth faltering when fed IC an Energy and Nutrient Dense Formula (ENDF).
Study design: A prospective, single-centre, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Infants aged from 1 month to \/= 1 month)
- •* Infants \>/=37 weeks gestation at time of recruitment
- •* Parent/ legal guardian willing to provide written informed consent
排除标准
- •Exclusively Breastfed infants
- •Infants with other medical problems that might independently affect intake (oral or otherwise) or who have specific nutrient needs not met by IC e.g. some gastrointestinal malformations, some renal and liver conditions, inborn errors of metabolism, galactosemia
- •Infants on total parenteral nutrition
- •Infants with cow milk protein allergy
- •Infants with soy allergy
- •Infants who participated in other studies within 2 weeks prior to recruitment
- •Situations where the investigator has concerns about the willingness or ability of the parents/caregivers to comply with protocol requirements
- •Infants who are on a vegan diet
- •Infants who are allergic to fish
- •Infants born preterm <37 weeks gestation
研究组 & 干预措施
Interventional
干预措施: Infant Formula (Other)
结局指标
主要结局
Body Weight
时间窗: 8 weeks
Body Weight
Change in body weight
时间窗: 8 weeks
The primary outcome is the change in weight-for-age Z-score from baseline to study completion, regardless of whether the value increases or decreases.
次要结局
未报告次要终点