NCT03728764已完成不适用
Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study
Société des Produits Nestlé (SPN)4 个研究点 分布在 3 个国家目标入组 34 人开始时间: 2018年10月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Growth of preterm infants
研究概览
简要总结
This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.
详细描述
This open-label trial will be conducted in up to 74 preterm infants to evaluate the formula as it would typically be used in the neonatal care unit and to document the safety and suitability of the two-stage feeding system in terms of growth in comparison to recommended growth goals, feeding tolerance, biochemical parameters, and adverse event reporting.
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
- — 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent has been obtained from the parents/legally acceptable representative (LAR).
- •Infant's birth weight ≤1500 g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart.
- •Infant's gestational age ≥ 27 weeks and ≤ 32 weeks.
- •Infant is clinically stable.
- •Infants are eligible to start experimental formula within the first 5 days (≤120 hours) of life.
排除标准
- •Parents not willing / not able to comply with the requirements of study protocol.
- •Infants experiencing early onset sepsis.
- •Major congenital or chromosomal abnormality known to affect growth.
- •Preterm infants experiencing liver failure.
- •Peri-/intra-ventricular haemorrhage.
- •Infant requiring prolonged (more than 3 doses) of steroid treatment.
- •Infants' participation in another interventional clinical trial.
研究组 & 干预措施
single arm
Other
干预措施: Preterm infant formula (Other)
结局指标
主要结局
Growth of preterm infants
时间窗: from FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier
Weight gain
次要结局
- Other growth parameter at other time points(from Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth) and at 30-days PD.)
- Other growth parameter(from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD ..)
- Feeding intake:(Daily during 30 days after hospital discharge)
- Feeding tolerance:(during the three days prior to the 30-day PD visit)
- Neonatal unit routine blood collection for safety assessment (serum blood levels of blood urea nitrogen (BUN), creatinine, albumin, pre albumin)(will be obtained at Enrolment (baseline), if possible, Pre-FEF Day 1, FEF Day1, thereafter weekly until hospital discharge (on average 7 weeks after birth)., and lastly at 30 days post-discharge.)
- Number of AEs reported for safety assessment(from the time the mother has consented to the infant's participation in the study soon after birth but no later than 5 days of age after birth until the 30 days PD visit in the clinic.)
- Other growth parameter(from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.)
- Feeding intake:(daily between Pre-FEF day 1 and hospital discharge (on average 7 weeks after birth))
- Feeding tolerance:(weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth))
研究者
研究点 (4)
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