NCT03604042已完成不适用
Comparison of Two Regimens of Individualized, Adjustable Human Milk Fortification in Pretem Infants Using a New Modular Protein-only Fortifier
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年10月9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
- 68
- 试验地点
- 1
- 主要终点
- Comparison of weight gain
研究概览
简要总结
The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.
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
- Single (Participant)
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age in weeks: 23 weeks 0 days and 31 weeks 6 days.
- •Birth weight less or equal to 1500 g
- •Minimum enteral intake of 150-160 mL/kg/d fortified HM
- •Parents, liable parent, or legal representative (LR) if applicable are willing and able to sign written informed consent and written informed consent is obtained prior to trial entry
排除标准
- •Infants with weight z-score < -2 SD, based on the Fenton growth chart (Fenton 2013)
- •Intra-ventricular hemorrhage (grade 3-4) determined using cranial ultrasonography or periventricular leukomalacia.
- •Renal disease determined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased creatinine.
- •Cholestasis (total bilirubin > 5 mg/dL or 85 umol/L and direct bilirubin > 20% of total bilirubin) associated with one or more abnormal liver function tests (AST, ALT, or GGT).
- •Major congenital malformations that may impact ability to accept enteral feedings (i.e., severe cleft palate, etc.).
- •Suspected or documented systemic or congenital infections (i.e., human immunodeficiency virus, cytomegalovirus, etc.).
- •Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth, e.g.,:
- •NEC grade above or equal to 2
- •Uncontrolled sepsis
- •Suspected or documented maternal substance abuse:
- •Born to mothers who smoked > 10 cigarettes per day during pregnancy
- •Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (> 3 alcoholic beverages per week) during pregnancy
- •Subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
- •Infants who have received any experimental treatment or received any other investigational intervention (procedure or product) unrelated to this trial, prior to enrollment
研究组 & 干预措施
Weight-driven protein fortification
Active Comparator
Individualized protein fortification based on weight gain
干预措施: Protein fortifier (Combination Product)
BUN-driven protein fortification
Experimental
Individualized protein fortification based on BUN concentrations
干预措施: Protein fortifier (Combination Product)
结局指标
主要结局
Comparison of weight gain
时间窗: From Day 6 to Day 27
To compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a BUN-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen
次要结局
- Weight at hospital discharge(Day 27 (minimum))
- Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)(Day 6 to Day 27 (minimum))
- Body composition including lean fat mass and fat-free mass(Day 6 to Day 27 (minimum))
- Comparison of weight gain (g/day) of infants after 1 and 3 weeks of individualized protein fortification to weight gain during the 5-day period of standard Human Milk (HM) fortification(Day 6 to Day 13, and Day 6 to Day 27)
- Changes in growth parameters: head circumference and head circumference gain (cm)(Day 6 to Day 27 (minimum))
- Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)(Day 6 to Day 27 (minimum))
- Macronutrient content in human milk(Day 6 to Day 27 (minimum))
- Feeding and gastrointestinal (GI) tolerance(Day 6 to Day 27 (minimum))
- Safety evaluation including number of subjects with AEs(Day 1 to Day 27 (minimum))
- Biochemistry markers collected from blood and urine as part of routine NICU standard of care(Day 6 to Day 27 (minimum))
研究者
研究点 (1)
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