Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Growth in terms of weight gain per day
研究概览
简要总结
This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.
详细描述
When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 33 weeks 0 days
- •Birth weight less than or equal to 2000g.
- •Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks
- •At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings.
- •Written informed consent has been obtained from the parent/legally authorized representative (LAR).
排除标准
- •Peri-/intra-ventricular hemorrhage
- •Renal disease
- •Hepatic dysfunction
- •Major congenital malformations
- •Suspected or documented systemic or congenital infections
- •Cardiac, respiratory, endocrinologic, hematologic, GI, or other systemic diseases that may impact growth
- •Suspected or documented maternal substance abuse
- •Infants who have received any experimental treatment or intervention
研究组 & 干预措施
Control Formula
Standard formula for preterm infants.
干预措施: Standard formula for preterm infants (Other)
Experimental formula
Formula with higher protein and new fat blend for preterm infants.
干预措施: Formula with higher protein and new fat blend for preterm infants (Other)
结局指标
主要结局
Growth in terms of weight gain per day
时间窗: 21 days
次要结局
- Growth in terms of length and head circumference(Till infant reaches 3kg (study completion), expected within 3 months)
- Feeding tolerance (frequency of regurgitation, stool frequency and consistency)(Till infant reaches 3kg (study completion), expected within 3 months)
- Incidence of adverse events(30 days post infant stopping study infant formula intake upon reaching 3kg)