NCT01208493终止不适用
Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance
Société des Produits Nestlé (SPN)8 个研究点 分布在 4 个国家目标入组 70 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- comparison of weight gain between both study groups as a measure of safety
研究概览
简要总结
In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.
Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed.
After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age <32 w, determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof
- •Birth weight ≤1500 g
- •Tolerating an enteral intake of ≥100 ml/kg/d for ≥ 24 h
- •Subject is anticipated to receive the study formula for ≥ 3 consecutive weeks after FEF have been achieved
- •In infants fed human milk, formula is anticipated to provide 50% or more of total energy intake, calculated on a weekly basis and based on the assumption that human milk has an energy density of 67 kcal/dl
- •Written informed consent has been obtained from the legal representative
排除标准
- •Cardiac failure requiring fluid restriction with diuretic therapy for ≥ 3 consecutive days
- •Peri-/intra-ventricular haemorrhage (grade 3-4) determined using cranial ultrasonography
- •Renal disease: by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased BUN and creatinine
- •Sepsis: defined by symptoms requiring antibiotic therapy and confirmed by a positive blood culture
- •Necrotizing Enterocolitis: defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3)
- •Hepatic dysfunction: defined by jaundice (direct bilirubin >1.0 mg/dl) which is associated with one or more abnormal liver function tests (AST, ALT or GGT)
- •Lung disease, severe enough to require steroid therapy.
- •Small size for gestational age (SGA) - body weight ≤ 5th percentile for that gestational age.
- •Participation in another clinical trial that may affect outcomes of this study
结局指标
主要结局
comparison of weight gain between both study groups as a measure of safety
时间窗: 3 weeks
次要结局
- comparison of feeding tolerance and metabolic status between study groups as a measure of safety(3 weeks)
研究者
研究点 (8)
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