The Effects of Dietary Palmitic Acid Triacylglyceride Position on Anthropometric Measures, Bone Strength Parameters, Stool Characteristics and Stool Biochemistry in Preterm and Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- bone strength parameters
研究概览
简要总结
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.
详细描述
InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the results of a unique fatty acid composition on the glycerol backbone, which ensure high level of palmitic acid at the middle (sn-2) position.
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters, anthropometric parameters, wellbeing and stool characteristics in term and preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
- •Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
- •The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
- •The infant is apparently healthy.
- •Parental/ legal guardian written inform consent
- •Apgar after 5 minutes >7
- •Enrolled within their first 14 days of life for term infants and first month of life for preterm infants
- •At enrollment: clinical stability and acceptable weight gain
排除标准
- •The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome)
- •The infant suffer from neonatal morbidities:
- •Bronchopulmonary dysplasia (BPD)
- •Intraventricular Hemorrhage3-4 (IVH)
- •Necrotizing Enterocolitis (NEC)
- •Laboratory or clinical sings of Osteopenia
- •The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
- •The mother suffers from any disease or disability that may interfere with her ability to take care of her infant
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study
结局指标
主要结局
bone strength parameters
时间窗: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
次要结局
- Antropometric measurements(baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks)
- stool characteristics(baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks)