NCT01766011已完成2 期
Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 7
- 主要终点
- Weight gain per day
研究概览
简要总结
The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects eligible for study participation will satisfy the following criteria:
- •Birth weight between 1000g -1800g
- •Less than or equal to 34 weeks and 0 days gestational age at birth
- •Appropriate for gestational age (AGA)
- •Singleton or twin births
- •Infant is 21 days of age or less
排除标准
- •Infants with the following conditions prior to and/or at the time of study product initiation are not eligible for entry into the study:
- •Expected to be transferred to another facility within 14 days
- •Serious congenital abnormalities that may affect growth and development
- •Intubated for ventilation at the time of study product initiation
- •Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH)
- •Maternal incapacity, maternal drug or alcohol abuse during pregnancy or current abuse, or maternal treatment consistent with human immunodeficiency virus therapy
- •Infant has a history of major surgery
- •Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia
- •Confirmed necrotizing enterocolitis or confirmed sepsis
- •Current use or planned use of probiotics
- •Participation in another study that has not been approved
研究组 & 干预措施
study pre-term formula
Experimental
Pre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles
干预措施: study pre-term formula (Other)
结局指标
主要结局
Weight gain per day
时间窗: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
weight gain per day (g/kg/d)
次要结局
- Alkaline Phosphatase(SDAY 1, 15, and 29 or hospital discharge (whichever comes first))
- Length(Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first)
- Any periods of nil per os (NPO)(Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first)
- Daily Stool Questionnaire(Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first)
- Serum Calcium(SDAY 1, 15, and 29 or hospital discharge (whichever comes first))
- Head circumference(Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first)
- Daily Feeding Questionnaire(Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first)
- Phosphorus(SDAY 1, 15, and 29 or hospital discharge (whichever comes first))
研究者
研究点 (7)
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