NCT06212427招募中不适用
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study
Société des Produits Nestlé (SPN)12 个研究点 分布在 2 个国家目标入组 188 人开始时间: 2023年11月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 12
- 主要终点
- Feeding tolerance
研究概览
简要总结
The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.
A comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.
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
- 0 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR], if applicable)
- •Infant's parent(s)/LAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol
- •Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound
- •Infant birth weight ≤ 2500g
- •Infant postnatal age ≤ 14 days
- •Infant has tolerated trophic feeds (e.g., 10-15 mL/kg/day) for at least 24 hours but has not yet reached full enteral feeding
排除标准
- •Infant is clinically unstable, for example:
- •Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP < 5th percentile for age for at least three hours), or is receiving vasopressor drugs
- •Infant has received an exchange transfusion within the past 48 hours
- •Infant has had an episode of severe asphyxia at birth (PH less than 7.0)
- •Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)
- •Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
- •Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
- •Participation in another interventional clinical study that may interfere with the results of this study
结局指标
主要结局
Feeding tolerance
时间窗: From birth until achievement of full enteral feeding (1 to 3 weeks)
Time to reach full enteral feeding rate of 150 mL/kg/day
次要结局
- Gastrointestinal tolerance(From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks)
- Weight gain(From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks)
- Head circumference gain(From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks)
- Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)(From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks)
- Length gain(From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks)
研究者
研究点 (12)
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